Former CinCor execs reunite to helm new biotech startup

Former CinCor execs reunite to helm new biotech startup

    17 Sep 2025

Dive Brief: AllRock Bio, a biotechnology startup founded by a team of former CinCor...

CSL nabs option to acquire a startup and its blood-clotting drug

CSL nabs option to acquire a startup and its blood-clotting drug

    16 Sep 2025

Dive Brief: Just weeks after announcing a major restructuring, Australian drugmaker CSL struck a...

A key CDC panel meets this week to discuss vaccines. Here’s what to know.

A key CDC panel meets this week to discuss vaccines. Here’s what to know.

    16 Sep 2025

A federal vaccine panel will meet this week for the second time since it...

ATyr shares plunge on trial miss in inflammatory lung disease

ATyr shares plunge on trial miss in inflammatory lung disease

    15 Sep 2025

Dive Brief: An experimental drug from biotechnology company aTyr Pharma missed its main goal...

Novo Nordisk to lay off 9,000 workers in major restructuring

Novo Nordisk to lay off 9,000 workers in major restructuring

    15 Sep 2025

Dive Brief: Novo Nordisk on Wednesday announced plans to lay off about 11% of...

Kriya, Odyssey secure ‘megarounds’; Amgen boosts R&D leadership

Kriya, Odyssey secure ‘megarounds’; Amgen boosts R&D leadership

    14 Sep 2025

Today, a brief rundown of news involving Kriya Therapeutics and Odyssey Therapeutics, as well...

FDA shares guidance to drugmakers developing non-opioid pain medicines

FDA shares guidance to drugmakers developing non-opioid pain medicines

    14 Sep 2025

Dive Brief: The Food and Drug Administration on Wednesday issued draft recommendations for drugmakers...

Child dies in Capsida study of rare disease gene therapy

Child dies in Capsida study of rare disease gene therapy

    13 Sep 2025

Dive Brief: Capsida Biotherapeutics has suspended a recently begun clinical trial of an experimental...

Ozempic for cancer? Signs point to potential benefits of GLP-1s in oncology

Ozempic for cancer? Signs point to potential benefits of GLP-1s in oncology

    13 Sep 2025

What could GLP-1 drugs, known for their powerful weight loss benefits, have to do...

Takeda poaches top Lilly exec; Maze soars on early PKU drug data

Takeda poaches top Lilly exec; Maze soars on early PKU drug data

    12 Sep 2025

Today, a brief rundown of news involving Takeda Pharmaceutical and Maze Therapeutics, as well...

Prasad regains role as FDA’s top doctor, scientist

Prasad regains role as FDA’s top doctor, scientist

    12 Sep 2025

Senior Food and Drug Administration official Vinay Prasad has reclaimed a role as the...

FDA clears J&J’s drug-device combo for bladder cancer

FDA clears J&J’s drug-device combo for bladder cancer

    11 Sep 2025

Dive Brief: The Food and Drug Administration on Tuesday approved a drug-device combination for...

LB Pharmaceuticals raises $285M in first major biotech IPO since February

LB Pharmaceuticals raises $285M in first major biotech IPO since February

    11 Sep 2025

LB Pharmaceuticals raised $285 million in an initial public offering on Wednesday, marking the...

[Podcast] The Progress Profile: Alzheimer’s Research in Focus

[Podcast] The Progress Profile: Alzheimer’s Research in Focus

    10 Sep 2025

This compelling four-part podcast series, “The Progress Profile: Alzheimer’s Research in Focus,” brings together...

Lilly to give biotech startups access to AI tools

Lilly to give biotech startups access to AI tools

    10 Sep 2025

Eli Lilly will give small biotechnology companies a chance to use artificial intelligence models...

A new class of sleep drugs draws Wall Street’s attention

A new class of sleep drugs draws Wall Street’s attention

    09 Sep 2025

Drug developers from around the world rang in a new era of sleep medicine...

BioNTech says dual-acting lung cancer drug helped shrink tumors

BioNTech says dual-acting lung cancer drug helped shrink tumors

    09 Sep 2025

Dive Brief: BioNTech’s experimental bispecific cancer drug pumitamig helped shrink tumors in three-quarters of...

Harnessing the power of AI to detect ATTR-CM

Harnessing the power of AI to detect ATTR-CM

    08 Sep 2025

Artificial intelligence (AI) has quietly become a part of our daily lives – through...

A drug discovery startup banks $150M for immune and obesity drugs

A drug discovery startup banks $150M for immune and obesity drugs

    08 Sep 2025

Dive Brief: Enveda Biosciences said Thursday it raised $150 million in Series D financing,...

Sanofi’s touted eczema drug hits study goal, but data fall short of expectations

Sanofi’s touted eczema drug hits study goal, but data fall short of expectations

    07 Sep 2025

Dive Brief: Sanofi shares dropped after the French drugmaker reported results from a highly...

FDA outlines new review pathway for drugs treating ultra-rare diseases

FDA outlines new review pathway for drugs treating ultra-rare diseases

    07 Sep 2025

Dive Brief: The Food and Drug Administration plans to work more closely and flexibly...

Bravehart, a stealthy startup, looks to China to challenge Bristol Myers heart drug

Bravehart, a stealthy startup, looks to China to challenge Bristol Myers heart drug

    06 Sep 2025

A newly launched startup is the latest young company to build itself around a...

FDA to publish CRLs in real time; PEPFAR to distribute Gilead’s Yeztugo

FDA to publish CRLs in real time; PEPFAR to distribute Gilead’s Yeztugo

    06 Sep 2025

Today, a brief rundown of news involving the Food and Drug Administration and Gilead...

Atlas Venture reels in $400M to grow its biotech startups

Atlas Venture reels in $400M to grow its biotech startups

    05 Sep 2025

Prolific biotechnology investment firm Atlas Venture said Thursday it raised $400 million to pump...

At Senate hearing, lawmakers express dissatisfaction with RFK Jr.’s vaccine moves

At Senate hearing, lawmakers express dissatisfaction with RFK Jr.’s vaccine moves

    05 Sep 2025

U.S. lawmakers clashed with Health and Human Services Secretary Robert F. Kennedy Jr. over...

Secretive startup Treeline unveils first clinical candidates, $200M in new funding

Secretive startup Treeline unveils first clinical candidates, $200M in new funding

    04 Sep 2025

For the past four years or so, veteran drug hunters Josh Bilenker and Jeff...

Biohaven’s rare disease drug is ‘ready to ship on Day 1’ following FDA approval

Biohaven’s rare disease drug is ‘ready to ship on Day 1’ following FDA approval

    04 Sep 2025

Biohaven’s top executive said his team is well-prepared to sell a therapy that could...

Novartis thinks Arrowhead brain drug can succeed where others couldn’t

Novartis thinks Arrowhead brain drug can succeed where others couldn’t

    03 Sep 2025

Novartis is once again taking aim at Parkinson’s disease, through a deal with Arrowhead...

Amgen to invest $600M in new US center; Sanofi drug for ITP approved

Amgen to invest $600M in new US center; Sanofi drug for ITP approved

    03 Sep 2025

Today, we’re catching up after a long weekend on news involving Amgen and Replimune,...

Startup Corsera Health aims to bring preventive heart medicine to the masses

Startup Corsera Health aims to bring preventive heart medicine to the masses

    02 Sep 2025

The biotechnology careers of John Maraganore and Clive Meanwell have brought them into collaboration...

Why an FDA decision on Stealth’s Barth drug could ripple through the rare disease field

Why an FDA decision on Stealth’s Barth drug could ripple through the rare disease field

    31 Aug 2025

The case of Stealth BioTherapeutics and its rare disease drug could become a regulatory...

Startup Wugen raises $115M for ‘off-the-shelf’ CAR-T

Startup Wugen raises $115M for ‘off-the-shelf’ CAR-T

    30 Aug 2025

Dive Brief: Wugen said Wednesday that it brought in $115 million in a new...

Amylyx drug comes up short; Sanofi names new CMO

Amylyx drug comes up short; Sanofi names new CMO

    30 Aug 2025

Today, a brief rundown of news involving Amylyx Pharmaceuticals and Sanofi, as well as...

Novo strikes RNA drug deal with startup Replicate

Novo strikes RNA drug deal with startup Replicate

    29 Aug 2025

Dive Brief: Novo Nordisk is again looking for help outside its own laboratories as...

CDC panel to discuss COVID, hepatitis B shots in meeting next month

CDC panel to discuss COVID, hepatitis B shots in meeting next month

    29 Aug 2025

A federal vaccine panel recently remade by Health and Human Services Secretary Robert F....

Lilly says breast cancer drug extended survival in study

Lilly says breast cancer drug extended survival in study

    28 Aug 2025

Dive Brief: People with early breast cancer who were treated in a late-stage study...

FDA approves updated COVID boosters, but narrows use

FDA approves updated COVID boosters, but narrows use

    28 Aug 2025

The Food and Drug Administration on Wednesday approved updated COVID-19 vaccines that target a...

RNA drug from Regeneron, Alnylam succeeds in rare autoimmune disease trial

RNA drug from Regeneron, Alnylam succeeds in rare autoimmune disease trial

    27 Aug 2025

Dive Brief: An RNA medicine developed by Regeneron Pharmaceuticals and Alnylam Pharmaceuticals helped control...

Lilly to submit obesity pill after hitting goal in third late-stage trial

Lilly to submit obesity pill after hitting goal in third late-stage trial

    27 Aug 2025

Dive Brief: Eli Lilly on Tuesday said it is ready to ask the Food...

FDA suspends license for Valneva’s chikungunya shot

FDA suspends license for Valneva’s chikungunya shot

    26 Aug 2025

The Food and Drug Administration has suspended the license of Valneva’s chikungunya vaccine following...

Royalty Pharma buys BeOne stake in Amgen lung cancer drug sales

Royalty Pharma buys BeOne stake in Amgen lung cancer drug sales

    26 Aug 2025

Dive Brief: Royalty Pharma has grabbed rights to a share in revenue from lung...

MAHA may take aim at pharma DTC ads

MAHA may take aim at pharma DTC ads

    25 Aug 2025

A much-anticipated report from the Make America Healthy Again Commission was postponed earlier this...

Rocket can resume gene therapy trial after FDA lifts hold

Rocket can resume gene therapy trial after FDA lifts hold

    24 Aug 2025

Dive Brief: Rocket Pharmaceuticals plans to restart a Phase 2 gene therapy trial for...

US, EU agree to terms of framework trade pact

US, EU agree to terms of framework trade pact

    24 Aug 2025

The United States and the European Union formalized the terms of the framework trade...

Sarepta pushes off debt payments in bid to regain financial footing

Sarepta pushes off debt payments in bid to regain financial footing

    23 Aug 2025

Dive Brief: Sarepta on Thursday said it’s reached agreements that remove about $700 million...

FDA cancels adcomm on Biohaven drug; Catalent lays off staff

FDA cancels adcomm on Biohaven drug; Catalent lays off staff

    23 Aug 2025

Today, a brief rundown of news involving Biohaven and Catalent, as well as updates...

Gilead dives into ‘in vivo’ cell therapy with $350M buyout of Interius

Gilead dives into ‘in vivo’ cell therapy with $350M buyout of Interius

    22 Aug 2025

Dive Brief: Gilead Sciences is deepening its investment in cancer cell therapy, announcing Thursday...

FDA approves Ionis’ hereditary angioedema drug

FDA approves Ionis’ hereditary angioedema drug

    22 Aug 2025

The Food and Drug Administration on Thursday approved a drug Ionis Pharmaceuticals developed for...

Lilly searching for new neuro chief as White set to retire

Lilly searching for new neuro chief as White set to retire

    21 Aug 2025

Eli Lilly is searching for a new neuroscience chief after announcing Wednesday that the...

Xoma, a drug royalty specialist, buys another ‘zombie’ biotech

Xoma, a drug royalty specialist, buys another ‘zombie’ biotech

    21 Aug 2025

Xoma Royalty Corp. is acquiring another struggling biotechnology company in further sign of interest...

CSL to separate vaccine business, cut jobs

CSL to separate vaccine business, cut jobs

    20 Aug 2025

Dive Brief: Australian drugmaker CSL is separating its vaccine business, Seqirus, into a standalone...

Viking shares sink as obesity pill misses expectations in key study

Viking shares sink as obesity pill misses expectations in key study

    20 Aug 2025

Dive Brief: An experimental weight loss pill from Viking Therapeutics helped people with obesity...

Omega’s Otello Stampacchia on the ‘reset’ changing biotech for the better

Omega’s Otello Stampacchia on the ‘reset’ changing biotech for the better

    19 Aug 2025

Otello Stampacchia has watched the biotechnology industry survive many dark days in the two...

Stealth resubmits rare disease drug to FDA

Stealth resubmits rare disease drug to FDA

    19 Aug 2025

Dive Brief: Stealth BioTherapeutics is once again seeking U.S. approval of a drug for...

Navigating the oncology patent cliff: Strategic imperatives for big pharma

Navigating the oncology patent cliff: Strategic imperatives for big pharma

    18 Aug 2025

Over the next five years, several blockbuster oncology drugs from leading pharmaceutical companies will...

With FDA PreCheck, drugmakers may get a manufacturing boost

With FDA PreCheck, drugmakers may get a manufacturing boost

    18 Aug 2025

The Trump administration recently added to an ongoing push to boost pharmaceutical manufacturing in...

Vedanta, PureTech’s microbiome startup, to cut staff after study setback

Vedanta, PureTech’s microbiome startup, to cut staff after study setback

    17 Aug 2025

Vedanta Biosciences, a startup working on microbiome drug research for more than a decade,...

Merck KGaA ventures into new territory in the US

Merck KGaA ventures into new territory in the US

    17 Aug 2025

Merck KGaA has been making moves to propel itself into becoming what CEO Belén...

Precigen wins immunotherapy approval; Pfizer sickle cell drug fails trial

Precigen wins immunotherapy approval; Pfizer sickle cell drug fails trial

    16 Aug 2025

Today, a brief rundown of news involving Precigen and Pfizer, as well as updates...

HHS revives defunct task force on childhood vaccine safety

HHS revives defunct task force on childhood vaccine safety

    16 Aug 2025

The Department of Health and Human Services announced Thursday it will reinstate a disbanded...

Sarepta sells Arrowhead shares as partnership, debt payments loom

Sarepta sells Arrowhead shares as partnership, debt payments loom

    15 Aug 2025

Dive Brief: Sarepta on Wednesday announced the divestment of its entire equity stake in...

Lilly says it will raise drug prices in Europe, responding to Trump threats

Lilly says it will raise drug prices in Europe, responding to Trump threats

    15 Aug 2025

Eli Lilly on Thursday responded to a Trump administration plan to lower U.S. drug...

Vor says drug licensed from RemeGen succeeded in Sjögren’s study

Vor says drug licensed from RemeGen succeeded in Sjögren’s study

    14 Aug 2025

Dive Brief: Vor Biopharma on Wednesday said a late-stage study run in China by...

AbbVie to build API plant in Illinois as it steps up US production

AbbVie to build API plant in Illinois as it steps up US production

    14 Aug 2025

AbbVie plans to spend $195 million to build a new facility to produce active...

PureTech launches new biotech built around lung disease drug

PureTech launches new biotech built around lung disease drug

    13 Aug 2025

Dive Brief: PureTech Health, a biotechnology firm with a web of startup subsidiaries, announced...

Insmed gains US approval of lung disease drug forecast to be blockbuster

Insmed gains US approval of lung disease drug forecast to be blockbuster

    13 Aug 2025

Dive Brief: Insmed has gained approval for its second lung disease medicine, announcing Tuesday...

IO Biotech sees path forward for skin cancer vaccine despite study setback

IO Biotech sees path forward for skin cancer vaccine despite study setback

    12 Aug 2025

An experimental cancer vaccine fell short of its main objective in a Phase 3...

Strand raises another $153M to make ‘programmable’ mRNA drugs

Strand raises another $153M to make ‘programmable’ mRNA drugs

    08 Aug 2025

Strand Therapeutics has raised a $153 million Series B round fresh off unveiling early,...

Iovance cuts staff amid slow sales start for ‘TIL’ cell therapy

Iovance cuts staff amid slow sales start for ‘TIL’ cell therapy

    07 Aug 2025

Iovance Biotherapeutics will lay off staff in a restructuring that follows a significant cut...

HHS abandons mRNA vaccine research

HHS abandons mRNA vaccine research

    07 Aug 2025

The Department of Health and Human Services is canceling nearly $500 million in contracts...

Pharma prepared to work with Trump on DTC drug sales: Pfizer CEO

Pharma prepared to work with Trump on DTC drug sales: Pfizer CEO

    06 Aug 2025

Pfizer and other large pharmaceutical companies are taking seriously President Donald Trump’s demand that...

US biotech needs government support to match China’s gains, Pfizer CEO says

US biotech needs government support to match China’s gains, Pfizer CEO says

    06 Aug 2025

Lawmakers in Washington share U.S. drugmakers’ angst about being surpassed by China’s fast-progressing biotechnology...

David Altshuler, geneticist who helped transform Vertex, to retire next year

David Altshuler, geneticist who helped transform Vertex, to retire next year

    05 Aug 2025

Dive Brief: David Altshuler, the renowned geneticist who’s helped shape Vertex Pharmaceuticals’ research strategy...

Gates Foundation pledges $2.5B toward women’s health research

Gates Foundation pledges $2.5B toward women’s health research

    05 Aug 2025

The Gates Foundation on Monday said it is committing to invest $2.5 billion over...

The race to scale to 1,000 liters and beyond in gene therapy manufacturing

The race to scale to 1,000 liters and beyond in gene therapy manufacturing

    04 Aug 2025

Viral-based gene therapies (GTs) represent a new frontier in medicine, offering hope to patients...

Venture firm Frazier closes $1.3B fund for early-stage biotech investing

Venture firm Frazier closes $1.3B fund for early-stage biotech investing

    04 Aug 2025

Frazier Life Sciences on Thursday said it has closed a new venture capital fund...

Alnylam reaches new highs on strong sales of closely watched rare disease drug

Alnylam reaches new highs on strong sales of closely watched rare disease drug

    03 Aug 2025

Dive Brief: Sales of an Alnylam Pharmaceuticals rare disease medicine substantially outpaced Wall Street...

In rumored AbbVie deal, Wall Street sees momentum for psychedelics M&A

In rumored AbbVie deal, Wall Street sees momentum for psychedelics M&A

    03 Aug 2025

Biotechnology companies specializing in psychedelics research saw their share prices rise after rumors of...

Experts ousted from CDC panel warn of damage to US vaccine policy

Experts ousted from CDC panel warn of damage to US vaccine policy

    02 Aug 2025

The 17 vaccine advisers fired by Robert F. Kennedy Jr. last month called Wednesday...

Regeneron cancer bispecific rejected again; Allogene discloses trial death

Regeneron cancer bispecific rejected again; Allogene discloses trial death

    02 Aug 2025

Today, a brief rundown of news involving Regeneron Pharmaceuticals and Allogene Therapeutics, as well...

US to install country-specific tariffs Aug. 7

US to install country-specific tariffs Aug. 7

    01 Aug 2025

The U.S. plans to lift its pause on country-specific tariffs while implementing a range...

Trump redoubles threats in attempt to strongarm drugmakers on prices

Trump redoubles threats in attempt to strongarm drugmakers on prices

    01 Aug 2025

President Donald Trump on Thursday threatened 17 large drugmakers with “every tool in [the...

Vinay Prasad’s ouster leaves biotech guessing at FDA direction

Vinay Prasad’s ouster leaves biotech guessing at FDA direction

    31 Jul 2025

Vinay Prasad’s sudden resignation from the Food and Drug Administration Tuesday once again leaves...

Madrigal buys into GLP-1 from CSPC; Apellis wins expanded drug approval

Madrigal buys into GLP-1 from CSPC; Apellis wins expanded drug approval

    31 Jul 2025

Today, a brief rundown of news involving Madrigal Pharmaceuticals and Viridian Therapeutics, as well...

Vinay Prasad, controversial FDA official, abruptly departs agency

Vinay Prasad, controversial FDA official, abruptly departs agency

    30 Jul 2025

Vinay Prasad, the controversial head of the Food and Drug Administration office that oversees...

Merck plans spending shift to boost business beyond Keytruda

Merck plans spending shift to boost business beyond Keytruda

    30 Jul 2025

Dive Brief: Merck & Co. is launching a new cost-cutting program, announcing Tuesday a...

Bavarian Nordic agrees to $3B take-private deal

Bavarian Nordic agrees to $3B take-private deal

    29 Jul 2025

Vaccine maker Bavarian Nordic on Monday said it has agreed in principle to a...

FDA allows Sarepta to resume some Elevidys shipments

FDA allows Sarepta to resume some Elevidys shipments

    29 Jul 2025

The Food and Drug Administration has given Sarepta Therapeutics a green light to resume...

Atai backs away from schizophrenia drug after trial failure

Atai backs away from schizophrenia drug after trial failure

    28 Jul 2025

The small, brain-focused biotechnology company Atai Life Sciences plans to direct resources away from...

Rocket lays off staff; Abivax capitalizes on immune drug data

Rocket lays off staff; Abivax capitalizes on immune drug data

    28 Jul 2025

Today, a brief rundown of news involving Rocket Pharmaceuticals and Atara Biotherapeutics, as well...

Galapagos, having backtracked on split, weighs sale of cell therapy business

Galapagos, having backtracked on split, weighs sale of cell therapy business

    27 Jul 2025

Dive Brief: Galapagos on Wednesday said it’s considering selling its cell therapy business, which...

In reversal, European regulators take positive view on Lilly Alzheimer’s drug

In reversal, European regulators take positive view on Lilly Alzheimer’s drug

    27 Jul 2025

A key committee that helps decide what new medicines enter the European market has...

Bristol Myers shuffles its executive ranks with new CMO

Bristol Myers shuffles its executive ranks with new CMO

    26 Jul 2025

AstraZeneca executive Cristian Massacesi will join Bristol Myers Squibb as its chief medical officer,...

FDA delays approval decision for Bayer menopause therapy

FDA delays approval decision for Bayer menopause therapy

    26 Jul 2025

The Food and Drug Administration has delayed its review of a Bayer therapy for...

Sarepta woes mount as Duchenne gene therapy knocked back in Europe

Sarepta woes mount as Duchenne gene therapy knocked back in Europe

    25 Jul 2025

European drug regulators on Friday recommended rejecting Sarepta Therapeutics’ Elevidys in the latest setback...

A TCG offshoot pulls in $400M for biotech startup creation

A TCG offshoot pulls in $400M for biotech startup creation

    25 Jul 2025

TCG Labs Soleil, a venture firm building narrowly focused biotechnology startups and readying them...

AstraZeneca drug acquired in Alexion deal succeeds in autoimmune disease trial

AstraZeneca drug acquired in Alexion deal succeeds in autoimmune disease trial

    24 Jul 2025

An experimental drug from AstraZeneca succeeded in a late-stage trial in an autoimmune condition...

RFK Jr. adopts CDC panel recommendation to remove thimerosal from flu shots

RFK Jr. adopts CDC panel recommendation to remove thimerosal from flu shots

    24 Jul 2025

Health and Human Services Secretary Robert F. Kennedy Jr. on Wednesday endorsed a federal...

Dispatch emerges with $216M and plans for a ‘universal’ solid tumor therapy

Dispatch emerges with $216M and plans for a ‘universal’ solid tumor therapy

    23 Jul 2025

Dive Brief: A new biotechnology company debuted Wednesday with a hefty bankroll and an...

Sanofi to acquire vaccine biotech in billion-dollar deal

Sanofi to acquire vaccine biotech in billion-dollar deal

    23 Jul 2025

Dive Brief: French pharmaceutical giant Sanofi said Tuesday it will pay $1.15 billion to...

Sarepta stops Elevidys shipments after standoff with FDA

Sarepta stops Elevidys shipments after standoff with FDA

    22 Jul 2025

Sarepta Therapeutics said Monday evening it will temporarily pause all shipments of its Elevidys...

AstraZeneca grows US presence with $50B in spending plans

AstraZeneca grows US presence with $50B in spending plans

    22 Jul 2025

WASHINGTON — AstraZeneca, the U.K.’s third biggest company by market value, is making itself...

From bench to batch: AAV manufacturing for the next-generation of gene therapies

From bench to batch: AAV manufacturing for the next-generation of gene therapies

    21 Jul 2025

The AAV-based therapeutic market continues to evolve rapidly. The past few years have seen...

Bristol Myers, Pfizer to offer Eliquis at a discount for some patients

Bristol Myers, Pfizer to offer Eliquis at a discount for some patients

    21 Jul 2025

Bristol Myers Squibb and Pfizer will begin offering their top-selling heart medicine Eliquis through...

Sarepta reports patient death in limb-girdle trial, compounding concerns on gene therapy risks

Sarepta reports patient death in limb-girdle trial, compounding concerns on gene therapy risks

    20 Jul 2025

Another person treated with a Sarepta Therapeutics gene therapy has died, compounding concerns about...

Bristol Myers’ Reblozyl falls short in Phase 3; Blenrep voted down by FDA panel

Bristol Myers’ Reblozyl falls short in Phase 3; Blenrep voted down by FDA panel

    20 Jul 2025

Today, a brief rundown of news involving Bristol Myers Squibb and the Food and...

Panel urges FDA to remove warnings on hormonal menopause therapy

Panel urges FDA to remove warnings on hormonal menopause therapy

    19 Jul 2025

A panel of medical experts called for the removal of warning labels on hormone...

FDA to ask Sarepta to stop shipping Duchenne gene therapy

FDA to ask Sarepta to stop shipping Duchenne gene therapy

    19 Jul 2025

The Food and Drug Administration will ask Sarepta Therapeutics to halt all shipments of...

Novartis CEO says resolution on Trump plan to cut US drug prices will take time

Novartis CEO says resolution on Trump plan to cut US drug prices will take time

    18 Jul 2025

Novartis is exploring options to meet the Trump administration’s goal of bringing U.S. drug...

Biotech startup funding dried up in second quarter, HSBC finds

Biotech startup funding dried up in second quarter, HSBC finds

    18 Jul 2025

Dive Brief: New data from HSBC Innovation Banking add further evidence venture capital funding...

AstraZeneca rare disease drug fails key trial tests

AstraZeneca rare disease drug fails key trial tests

    17 Jul 2025

An experimental rare disease drug from AstraZeneca failed in two late-stage trials, though the...

Sarepta to lay off about 500 employees after Duchenne gene therapy setbacks

Sarepta to lay off about 500 employees after Duchenne gene therapy setbacks

    17 Jul 2025

Sarepta Therapeutics is laying off roughly 500 employees in an extensive workforce reduction that...

Hengrui, Kailera say dual-acting obesity shot succeeds in China study

Hengrui, Kailera say dual-acting obesity shot succeeds in China study

    16 Jul 2025

Dive Brief: An experimental, dual-acting obesity drug from Hengrui Pharma and biotechnology startup Kailera...

Cancer drugmaker LaNova to sell to China’s Sino Biopharm

Cancer drugmaker LaNova to sell to China’s Sino Biopharm

    16 Jul 2025

Dive Brief: LaNova Medicines, a cancer drugmaker that previously licensed medicines to Merck &...

Private equity firms back PCI Pharma in bet on drug production

Private equity firms back PCI Pharma in bet on drug production

    15 Jul 2025

A group of private equity firms are pouring funding into PCI Pharma Services, betting...

AstraZeneca blood pressure drug succeeds in late-stage trial

AstraZeneca blood pressure drug succeeds in late-stage trial

    15 Jul 2025

Dive Brief: An experimental drug being developed by AstraZeneca significantly reduced blood pressure versus...

From data to decisions: How pharma can move faster without sacrificing trust

From data to decisions: How pharma can move faster without sacrificing trust

    14 Jul 2025

In a race where every day counts, speed has become a defining metric for...

AbbVie to pay $700M for trispecific drug from Ichnos Glenmark

AbbVie to pay $700M for trispecific drug from Ichnos Glenmark

    14 Jul 2025

Dive Brief: AbbVie agreed to pay Ichnos Glenmark $700 million upfront for rights to...

FDA, in policy shift, publishes some drug rejection letters

FDA, in policy shift, publishes some drug rejection letters

    13 Jul 2025

The Food and Drug Administration on Thursday published more than 200 drug rejection letters...

FDA turns back Capricor’s Duchenne cell therapy

FDA turns back Capricor’s Duchenne cell therapy

    13 Jul 2025

The Food and Drug Administration has rejected what was set to be the first...

With Verona deal, Merck wagers on strength of lung drug’s patents

With Verona deal, Merck wagers on strength of lung drug’s patents

    12 Jul 2025

Merck & Co.’s $10 billion acquisition of Verona Pharma Wednesday is a dramatic outcome...

Jazz names new CEO; Ultragenyx, Mereo shares slide on trial update

Jazz names new CEO; Ultragenyx, Mereo shares slide on trial update

    12 Jul 2025

Today, a brief rundown of news involving Valneva and Jazz Pharmaceuticals, as well as...

Moderna COVID vaccine gets full approval for children

Moderna COVID vaccine gets full approval for children

    11 Jul 2025

Dive Brief: The Food and Drug Administration on Thursday granted full approval for Moderna’s...

Soleno sales of new Prader-Willi drug rise faster than expected

Soleno sales of new Prader-Willi drug rise faster than expected

    11 Jul 2025

The first marketed treatment for the insatiable hunger associated with Prader-Willi disease is selling...

Renasant Bio, chasing drugs for ADPKD, raises $55M in seed funding

Renasant Bio, chasing drugs for ADPKD, raises $55M in seed funding

    10 Jul 2025

The drug industry’s efforts to develop a treatment for a rare kidney condition known...

Lilly gets FDA OK of modified dosing for Alzheimer’s drug

Lilly gets FDA OK of modified dosing for Alzheimer’s drug

    10 Jul 2025

Dive Brief: The Food and Drug Administration has approved a modified dosing schedule for...

Actithera draws new investors to radiopharma drug pitch

Actithera draws new investors to radiopharma drug pitch

    09 Jul 2025

Dive Brief: Actithera, a radiopharmaceutical drugmaker based in Oslo, Norway and Cambridge, Massachusetts, has...

Trump says pharmaceutical, copper tariffs coming ‘very soon’

Trump says pharmaceutical, copper tariffs coming ‘very soon’

    09 Jul 2025

President Donald Trump is planning to introduce tariffs of 50% on copper imports and...

Protein degraders: chasing undruggable targets

Protein degraders: chasing undruggable targets

    08 Jul 2025

For decades now, scientists have been experimenting with a new way to target and...

Medical groups, pregnant doctor sue RFK Jr. over vaccine changes

Medical groups, pregnant doctor sue RFK Jr. over vaccine changes

    08 Jul 2025

Six medical groups and a pregnant physician have sued Health and Human Services Secretary...

AbbVie to buy CAR-T developer Capstan in deal worth up to $2.1B

AbbVie to buy CAR-T developer Capstan in deal worth up to $2.1B

    04 Jul 2025

Dive Brief: Abbvie has agreed to acquire cell therapy developer Capstan Therapeutics in a...

Acadia CEO sets sights on ‘much more assertive’ deals to invigorate pipeline

Acadia CEO sets sights on ‘much more assertive’ deals to invigorate pipeline

    04 Jul 2025

Acadia Pharmaceuticals, the brain-focused drug developer, surprised some on Wall Street last week with...

Organon drug for endometriosis falls short in mid-stage study

Organon drug for endometriosis falls short in mid-stage study

    03 Jul 2025

Dive Brief: Organon’s experimental treatment for endometriosis failed to improve pelvic pain for women...

Regeneron bispecific approved for myeloma; Concentra to buy IGM

Regeneron bispecific approved for myeloma; Concentra to buy IGM

    03 Jul 2025

Today, a brief rundown of news involving Regeneron Pharmaceuticals, IGM Biosciences and Catalio Capital,...

Sodium channel blockers for pain: New opportunities after Vertex’s ‘watershed’ moment

Sodium channel blockers for pain: New opportunities after Vertex’s ‘watershed’ moment

    02 Jul 2025

In the notoriously expensive business of drug development, SiteOne Therapeutics made do with little....

Atai and Beckley, set to merge, reveal study success for psychedelic drug

Atai and Beckley, set to merge, reveal study success for psychedelic drug

    02 Jul 2025

Dive Brief: Atai Life Sciences and Beckley Psytech are making plans to push the...

Moderna flu shot outperforms marketed vaccines in large late-stage trial

Moderna flu shot outperforms marketed vaccines in large late-stage trial

    01 Jul 2025

Dive Brief: Moderna’s seasonal influenza vaccine met its main goal in a large Phase...

Sage to lay off most staff amid Supernus buyout

Sage to lay off most staff amid Supernus buyout

    01 Jul 2025

Dive Brief: Sage Therapeutics will lay off 338 employees, the vast majority of its...

Incyte replaces CEO Hoppenot with dealmaker Meury

Incyte replaces CEO Hoppenot with dealmaker Meury

    30 Jun 2025

Dive Brief: Incyte has named veteran pharmaceutical executive Bill Meury as its new CEO,...

Acadia’s ‘very bullish’ sales forecast restores some confidence on Wall Street

Acadia’s ‘very bullish’ sales forecast restores some confidence on Wall Street

    30 Jun 2025

Acadia Pharmaceuticals has proposed that its pipeline of experimental medicines could, if eventually brought...

Congress should reconsider breaking up PBMs, experts say

Congress should reconsider breaking up PBMs, experts say

    29 Jun 2025

Bipartisan policies in Congress meant to lower drug costs by targeting middlemen in the...

Supreme Court upholds ACA preventive services mandate

Supreme Court upholds ACA preventive services mandate

    29 Jun 2025

The Supreme Court on Friday upheld a popular provision of the Affordable Care Act that...

Biocryst sells Europe business; Peter Marks criticizes new FDA vaccine rules

Biocryst sells Europe business; Peter Marks criticizes new FDA vaccine rules

    28 Jun 2025

Today, a brief rundown of news involving Biocryst and Peter Marks, as well as...

FDA takes major step to ease access to CAR-T therapy

FDA takes major step to ease access to CAR-T therapy

    28 Jun 2025

Dive Brief: The Food and Drug Administration is easing limitations it imposed around the complex...

Vor, with new CEO, changes course to target autoimmune disease

Vor, with new CEO, changes course to target autoimmune disease

    27 Jun 2025

Dive Brief: Vor Biopharma is licensing rights to an immune disease drug from Chinese...

RFK Jr.-appointed panel recommends flu shots be free of contested preservative

RFK Jr.-appointed panel recommends flu shots be free of contested preservative

    27 Jun 2025

Dive Brief: Advisers to the Centers for Disease Control and Prevention recommended Thursday that...

Kymera adds Gilead as research partner, while advancing new candidate with Sanofi

Kymera adds Gilead as research partner, while advancing new candidate with Sanofi

    26 Jun 2025

Dive Brief: Kymera Therapeutics and Gilead Sciences will develop oral molecular glue degraders under...

CDC panel, newly remade by RFK Jr., questions vaccine evidence

CDC panel, newly remade by RFK Jr., questions vaccine evidence

    26 Jun 2025

Robert F. Kennedy Jr.’s newly hand-picked panel of federal vaccine advisers met for the...

Lexeo to help launch spinout around RNA drugs for the heart

Lexeo to help launch spinout around RNA drugs for the heart

    25 Jun 2025

Dive Brief: Perceptive Xontogeny Venture Funds and venBio Partners are contributing up to $40...

FDA investigating Elevidys safety; Nektar shares spike on eczema data

FDA investigating Elevidys safety; Nektar shares spike on eczema data

    25 Jun 2025

Today, a brief rundown of news involving Sarepta Therapeutics, Capricor Therapeutics and Nektar Therapeutics,...

Top drug official at FDA reportedly set to exit next month

Top drug official at FDA reportedly set to exit next month

    24 Jun 2025

Dive Brief: A top Food and Drug Administration official responsible for overseeing drug reviews...

Relentless innovation: Bold exploration in advancing therapeutic options for every patient, every discovery

Relentless innovation: Bold exploration in advancing therapeutic options for every patient, every discovery

    24 Jun 2025

On the heels of the BIO International Convention and as I reflect on the...

The rise of GLP-1 drugs: Transforming weight loss treatment

The rise of GLP-1 drugs: Transforming weight loss treatment

    23 Jun 2025

In the last episode of the podcast Balancing the Future, hosted by Chai Nussbaumer...

FDA clears CSL’s swelling disease drug; Regeneron loses 23andMe auction

FDA clears CSL’s swelling disease drug; Regeneron loses 23andMe auction

    22 Jun 2025

Today, a brief rundown of news involving CSL and Intellia Therapeutics, as well as...

Gene therapy faces fresh uncertainty as two more top FDA officials depart

Gene therapy faces fresh uncertainty as two more top FDA officials depart

    22 Jun 2025

Dive Brief: Two senior officials at the Food and Drug Administration office that regulates...

A longer ‘winter’: Public funding slowdown heightens pressure on biotech startups

A longer ‘winter’: Public funding slowdown heightens pressure on biotech startups

    21 Jun 2025

Biotechnology industry watchers were hopeful at the start of 2025. Venture funding appeared to...

Prothena to lay off majority of staff; Zealand shares obesity drug data

Prothena to lay off majority of staff; Zealand shares obesity drug data

    21 Jun 2025

Today, a brief rundown of news involving Prothena and Zealand Pharma, as well as...

A startup banks $66M to pursue ‘inclusive precision medicine’

A startup banks $66M to pursue ‘inclusive precision medicine’

    20 Jun 2025

Dive Brief: Actio Biosciences, a San Diego-based biotechnology startup, announced Wednesday it raised a...

Draig, a brain drug startup, debuts with $140M to treat depression

Draig, a brain drug startup, debuts with $140M to treat depression

    20 Jun 2025

Psychiatric medicine remains one of the more challenging and risky areas of drug research....

Scholar Rock drug preserves muscle in obesity trial

Scholar Rock drug preserves muscle in obesity trial

    19 Jun 2025

Dive Brief: A medicine developed to treat a genetic muscle-wasting disease can improve results...

FDA approves twice-yearly shot of Gilead drug for HIV prevention

FDA approves twice-yearly shot of Gilead drug for HIV prevention

    19 Jun 2025

The Food and Drug Administration has approved a new way to prevent HIV, clearing...

FDA to speed reviews for drugs supporting ‘national interests’

FDA to speed reviews for drugs supporting ‘national interests’

    18 Jun 2025

Food and Drug Administration Commissioner Martin Makary has proposed a dramatic expansion of the...

Lilly to acquire Verve in $1B bet on gene editing for heart disease

Lilly to acquire Verve in $1B bet on gene editing for heart disease

    18 Jun 2025

Dive Brief: Eli Lilly agreed to buy Verve Therapeutics for $1 billion, betting on...

Roche, waving off study failures, commits to Phase 3 trials for Parkinson’s drug

Roche, waving off study failures, commits to Phase 3 trials for Parkinson’s drug

    17 Jun 2025

Dive Brief: Roche will advance an experimental Parkinson’s disease drug with a mixed track...

Could the FDA take an indirect approach to regulate lab developed tests?

Could the FDA take an indirect approach to regulate lab developed tests?

    17 Jun 2025

When the deadline to appeal the court decision that blocked the Food and Drug...

FDA clears Nuvation lung cancer drug, setting up battle with Bristol Myers and Roche

FDA clears Nuvation lung cancer drug, setting up battle with Bristol Myers and Roche

    16 Jun 2025

Dive Brief: The Food and Drug Administration has approved a new oral medication for...

Insmed surges on lung drug data; Recursion cuts staff

Insmed surges on lung drug data; Recursion cuts staff

    16 Jun 2025

Today, a brief rundown of news involving Insmed and Recursion Pharmaceuticals, as well as...

Pharma’s wins and losses in the budget bill

Pharma’s wins and losses in the budget bill

    15 Jun 2025

The budget bill currently under consideration in Congress is big — and it’s complicated....

AstraZeneca forms an AI deal in China; Third Harmonic advances liquidation plans

AstraZeneca forms an AI deal in China; Third Harmonic advances liquidation plans

    15 Jun 2025

Listen to the article 4 min This audio is auto-generated. Please let us know...

Moderna wins FDA OK to widen use of RSV vaccine

Moderna wins FDA OK to widen use of RSV vaccine

    14 Jun 2025

The Food and Drug Administration has approved wider use of Moderna’s respiratory syncytial virus...

Novo, searching for a spark, plans late-stage trials for amylin drug

Novo, searching for a spark, plans late-stage trials for amylin drug

    14 Jun 2025

Dive Brief: Novo Nordisk is planning Phase 3 clinical trials for a obesity drug...

RFK Jr. reveals picks for influential vaccine panel

RFK Jr. reveals picks for influential vaccine panel

    13 Jun 2025

Health and Human Services Secretary Robert F. Kennedy Jr. on Wednesday continued his efforts...

BioNTech buys mRNA, courtroom rival CureVac in all-stock deal

BioNTech buys mRNA, courtroom rival CureVac in all-stock deal

    13 Jun 2025

Dive Brief: COVID vaccine maker BioNTech is buying rival CureVac, announcing Thursday an all-stock deal...

Bristol Myers bolsters radiopharma portfolio with PhiloChem deal

Bristol Myers bolsters radiopharma portfolio with PhiloChem deal

    12 Jun 2025

Dive Brief: Bristol Myers agreed to pay $350 million up front to Philochem for...

SpliceBio lands $135M for a new kind of eye gene therapy

SpliceBio lands $135M for a new kind of eye gene therapy

    12 Jun 2025

SpliceBio, a Spanish biotechnology company working on next-generation gene therapies, said Wednesday it raised...

Vaccine makers face fresh uncertainty after firing of CDC panel

Vaccine makers face fresh uncertainty after firing of CDC panel

    11 Jun 2025

Dive Brief: Health and Human Services secretary Robert F. Kennedy Jr., has abruptly fired...

Scorpion, fresh off Lilly deal, spins out startup Antares

Scorpion, fresh off Lilly deal, spins out startup Antares

    11 Jun 2025

Fresh off a multibillion-dollar deal with Eli Lilly, cancer drug startup Scorpion Therapeutics is...

Concentra to acquire Elevation in bid to eliminate another biotech ‘zombie’

Concentra to acquire Elevation in bid to eliminate another biotech ‘zombie’

    10 Jun 2025

Elevation Oncology has agreed to be acquired by an investment firm focused on buying...

Merck antibody drug for RSV approved by FDA

Merck antibody drug for RSV approved by FDA

    10 Jun 2025

The Food and Drug Administration has cleared a new treatment designed to protect infants...

The golden era of GLP-1 drugs: How will it impact medicine and society?

The golden era of GLP-1 drugs: How will it impact medicine and society?

    09 Jun 2025

Sometimes, the right advances in medicine catch the public’s imagination—opening a world of possibilities...

Lilly partners with Camurus in search of a long-lasting obesity drug

Lilly partners with Camurus in search of a long-lasting obesity drug

    09 Jun 2025

Dive Brief: Looking to defend its giant cardiometabolic health franchise, Eli Lilly is licensing...

Biotech funding plummets as Trump policies unnerve investors: Jefferies

Biotech funding plummets as Trump policies unnerve investors: Jefferies

    08 Jun 2025

The amount of funding going into biotechnology companies has fallen off over the last...

FDA’s AI tool ‘Elsa’ is here, and the industry has questions

FDA’s AI tool ‘Elsa’ is here, and the industry has questions

    08 Jun 2025

The Food and Drug Administration aims to roll out its new AI tool, called...

Otsuka tops Vera with kidney drug data; Regenxbio sinks on Duchenne update

Otsuka tops Vera with kidney drug data; Regenxbio sinks on Duchenne update

    07 Jun 2025

Today, a brief rundown of news involving Otsuka Pharmaceutical and Arvinas, as well as...

FDA meeting gives window into gene therapy field’s angst

FDA meeting gives window into gene therapy field’s angst

    07 Jun 2025

Anyone looking for evidence of genetic medicine’s enormous promise need only read of KJ...

Bispecific cancer drugs, data caveats and funding alarms: 3 takeaways from ASCO

Bispecific cancer drugs, data caveats and funding alarms: 3 takeaways from ASCO

    06 Jun 2025

New drugs, however heralded, take time to embed into clinical care. Enhertu, the powerful...

Cullinan doubles down on bispecifics for autoimmune disease with Genrix deal

Cullinan doubles down on bispecifics for autoimmune disease with Genrix deal

    06 Jun 2025

Dive Brief: After changing its name and focus, Cullinan Therapeutics is beefing up its...

Daiichi Sankyo struck gold with ‘ADC’ cancer drugs. Its new CEO has to figure out what’s next.

Daiichi Sankyo struck gold with ‘ADC’ cancer drugs. Its new CEO has to figure out what’s next.

    05 Jun 2025

CHICAGO — Hiroyuki Okuzawa holds an enviable position. The veteran Daiichi Sankyo executive took...

FDA to use new review tool on Sarepta’s gene therapy work

FDA to use new review tool on Sarepta’s gene therapy work

    05 Jun 2025

Dive Brief: The Food and Drug Administration has awarded Sarepta Therapeutics a new kind...

J&J data support earlier use of combo pill in prostate cancer

J&J data support earlier use of combo pill in prostate cancer

    04 Jun 2025

CHICAGO — A Johnson & Johnson drug currently used for advanced prostate cancer can help...

Bayer drug could ease side effects of common breast cancer treatment, detailed data show

Bayer drug could ease side effects of common breast cancer treatment, detailed data show

    04 Jun 2025

An experimental, non-hormonal drug from Bayer can reduce the hot flashes and other menopausal...

Bispecific competition, debating oral SERDs and a bold GLP-1 prediction

Bispecific competition, debating oral SERDs and a bold GLP-1 prediction

    03 Jun 2025

CHICAGO — The American Society of Clinical Oncology’s annual meeting is a forum for...

Kymera, with new data, takes early step toward a Dupixent-like pill

Kymera, with new data, takes early step toward a Dupixent-like pill

    03 Jun 2025

Dive Brief: An experimental protein-degrading drug from Kymera Therapeutics appeared safe and able to...

A vision for the future of lung cancer treatment

A vision for the future of lung cancer treatment

    02 Jun 2025

What we commonly refer to as “lung cancer” is in fact many different types...

A funding flashpoint, Pfizer’s $1B poster and AstraZeneca advertising

A funding flashpoint, Pfizer’s $1B poster and AstraZeneca advertising

    02 Jun 2025

CHICAGO — Funding cancer research isn’t usually a political flashpoint. But as the Trump...

At ASCO, Enhertu cements growing role in stomach cancer care

At ASCO, Enhertu cements growing role in stomach cancer care

    01 Jun 2025

AstraZeneca and Daiichi Sankyo’s targeted cancer medicine Enhertu helped participants in a late-stage clinical...

FDA clears Moderna’s new COVID vaccine, but with limits

FDA clears Moderna’s new COVID vaccine, but with limits

    01 Jun 2025

The Food and Drug Administration has granted an approval to Moderna’s next-generation COVID-19 vaccine,...

Keros lays off nearly half its staff; Astellas buys into a China biotech’s ADC

Keros lays off nearly half its staff; Astellas buys into a China biotech’s ADC

    31 May 2025

Today, a brief rundown of news involving Astellas Pharma and Keros Therapeutics, as well...

New Summit data could slow US approval plans for PD-1/VEGF drug

New Summit data could slow US approval plans for PD-1/VEGF drug

    31 May 2025

Dive Brief: A dual-acting drug developed by Summit Therapeutics and Akeso delayed tumor progression...

Intellia filing spurs safety concerns over CRISPR drug

Intellia filing spurs safety concerns over CRISPR drug

    30 May 2025

Dive Brief: Intellia Therapeutics shares dropped 25% early Thursday after the gene-editing company disclosed...