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‘It’ll be a challenge’: BIO chief Crowley addresses seismic FDA overhaul

8 hours ago

RFK Jr. has long criticized drug ads. He just slashed the FDA office that regulates them

9 hours ago

Eli Lilly sues large compounding pharmacies Empower, Strive over tirzepatide products

9 hours ago

Judge orders HHS, other agencies to 'undo' probationary worker firings

4 hours ago

Latest

Most read

Firings sweep across FDA as former leaders lament the gutting of drug agency

16 hours ago

European drug regulator seeks to ‘streamline’ biosimilar approval process

11 hours ago

Zus Health CEO Jonathan Bush on the future of health records

12 hours ago

Axsome reports Phase 3 depression fail for Sunosi

13 hours ago

Compass Therapeutics touts trial success in biliary tract cancer, but more data are needed

13 hours ago

Gubra’s AbbVie-partnered amylin looks competitive with Zealand’s in early trial

13 hours ago

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People

Q&A: Demis Hassabis talks 'turbocharging' Isomorphic with $600M, expanding into antibodies and the US

13 hours ago

Sanofi continues its bet on R&D by poaching GSK’s head of development

17 hours ago

What’s next after Marks? At FDA, questions over more top exits and future vision for drug agency

Yesterday

Financing

RNA editing startup raises $155M to bring liver and lung disease therapy into clinic

17 hours ago

Alphabet’s Isomorphic Labs raises $600M in biotech’s largest round of 2025

Yesterday

Exclusive: SV Health debuts Parkinson's biotech with backing from AbbVie and others

2 days ago

Startups

Inspirna, which was preparing for a Phase 3 cancer trial, has folded

Yesterday

Exclusive: Metsera CEO on what it takes to build an obesity biotech in 2025

5 days ago

Galatea Bio gets $25M to map genetic diversity of 10 million people, help pharma create new medicines

5 days ago

Deals

Bluebird gets new M&A bid, seeking to top private equity offer

4 days ago

Novo inks second obesity deal of the week, with Lexicon oral drug partnership worth up to $1B

4 days ago

Before Alumis went public via IPO, it tried doing a reverse merger with Acelyrin

4 days ago

In FocusSee all

‘People will die’: End of NIH grants guts work between academics and companies to counter next pandemic

4 days ago

Illumina was built on DNA. Its future could be biology’s next big wave

Last week

A California health tech company is letting AI run medical visits, from intake to diagnosis

Last week

Ahead of FDA decision, Alnylam faces the big question: Can it make money?

Last week

Endpoints Standouts

How the world's biggest pharma and biotech companies paid their typical worker in 2023

8 months ago

In biotech's uneven recovery, 50 startups raised megarounds in first half of 2024

9 months ago

Biopharma leaders charting a path for the industry's LGBTQ+ community

9 months ago

Peter Marks single-handedly approved Sarepta’s gene therapy — what does that mean for everyone else?

9 months ago

Peer review See all

Mar

28

On the heels of staff cuts, CRISPR Therapeutics COO departs; Changes galore at Bicycle

Mar

21

BridgeBio, Editas finance chiefs depart; Former FDA No. 2 joins Recursion's board

Mar

14

Merck diversity leader to retire this summer; Geron seeks commercial chops for next CEO

Mar

7

Tune’s CEO search ends as John McHutchison takes top spot; More from Pfizer’s leadership makeover

Feb

28

Pfizer vet William Pao’s next venture; Sanofi’s computational science exec leaves

Pharma channel feed

Yesterday

Updated: J&J’s third talc bankruptcy bid is stopped by Texas federal judge

A federal judge on Monday dismissed a Johnson & Johnson subsidiary’s third attempt to settle tens of thousands of talc cases through bankruptcy.

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Federal judge nixes FDA's lab-developed test rule, says it exceeded agency's authority

Yesterday

DC court sides with HHS in Vertex's fertility program fight

Yesterday

latest in Pharma

Merck’s PAH drug cuts risk of serious events by 76% in trial stopped for efficacy

Yesterday

Lykos’ interim CEO is set to step down

4 days ago

Judge tosses Amgen's challenge to Colorado drug review board, says suit is 'too speculative'

4 days ago

J&J beats Viatris in patent fight over its antipsychotic drug, staving off competition

4 days ago

CHMP recommends seven label expansions and one new approval, rejects Lilly Alzheimer's drug

4 days ago

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Marketing channel feed

6 days ago

J&J touts new survival data pitting lung cancer combo against AstraZeneca's rival

Johnson & Johnson released new data suggesting its lung cancer combination Rybrevant and Lazcluze beat AstraZeneca’s Tagrisso on overall survival.

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Novo Nordisk slashes Wegovy price by nearly two-thirds for cash-paying patients

4 weeks ago

Misleading exhibit booth panel lands NJ drugmaker an untitled letter from FDA

4 weeks ago

latest in Marketing

Eli Lilly expands Zepbound single-dose vial options at lower price

Last month

J&J's new cancer combo beats AstraZeneca's Tagrisso on survival in lung trial

2 months ago

Drugs are approved — and made available — faster in US than most of EU, data show

3 months ago

Novartis bolsters Fabhalta data in competition with AstraZeneca

3 months ago

RFK Jr. and Elon Musk want to ban pharma ads. They wouldn't be the first to try

4 months ago

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FDA+ channel feed

Yesterday

FDA sets new date for opioid-focused advisory meeting after earlier delay

A meeting of outside experts to discuss the FDA’s post-marketing requirements for opioid medications is now slated for May 5 after being postponed earlier this year.

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Marks’ exit at FDA rattles an already teetering biotech industry

Yesterday

FDA's Peter Marks resigns, says he won't accept Kennedy's 'misinformation and lies'

4 days ago

latest in FDA+

At long last, Novartis’ radiopharma drug Pluvicto gets an expanded label

4 days ago

FDA approves Sanofi's RNAi drug for hemophilia A and B

4 days ago

European regulator rejects Lilly's Alzheimer’s drug over potentially fatal side effects

4 days ago

FDA’s policy, communications staff likely to be among agency’s 3,500 staff cuts

5 days ago

Kennedy announces 10,000 job cuts at HHS, with major reductions expected at FDA, NIH and CDC

5 days ago

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Manufacturing channel feed

4 days ago

Milestone's shares dive after FDA again rejects drug for abnormal heart rhythm

Milestone Pharmaceuticals’ nasal spray failed for a second time to secure US approval to treat an arrhythmia disorder called paroxysmal supraventricular tachycardia.

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With tariffs on the way, generic drugmaking woes could hinder Trump’s reshoring plan

5 days ago

Chiesi pours €430 into new Italy site; Bharat’s first CGT site in India

5 days ago

latest in Manufacturing

WuXi Biologics’ licensing deals help offset Biosecure threat in the US

Last week

Three major questions on pharma tariffs Trump claims are on the way

Last week

Liver cancer drug combo gets second FDA rejection over manufacturing issues

Last week

AstraZeneca puts $2.5B toward first vaccine factory and second R&D site in China

Last week

Johnson & Johnson earmarks $55B to boost US capacity

Last week

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