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Sarepta seeks to expand Duchenne gene therapy Elevidys use to toddlers
12 hours ago
R&D
FDA+
HHS can require approval for drugmakers to apply 340B rebate models, court rules
12 hours ago
Pharma
Law
Deputy FDA chief mulls shaking up PDUFA reauthorization structure
14 hours ago
FDA+
FDA poses efficacy, safety questions over four cancer drugs ahead of two-day adcomm
14 hours ago
Pharma
FDA+
Amarin calls Hikma's drug label arguments 'idiosyncratic,' urges high court to decline case
15 hours ago
Pharma
Law
Lower attendance at cell and gene therapy conference mirrors challenged industry
15 hours ago
R&D
Cell/Gene Tx
In three patients, Rocket’s second heart gene therapy shows promise
16 hours ago
R&D
Cell/Gene Tx
Mark Cuban compounder joins Trump's new manufacturing initiative
17 hours ago
Pharma
Manufacturing
BioMarin makes Phase 3 buy, paying $270M for rare disease outfit Inozyme
17 hours ago
Deals
Pharma
FDA lifts hold on Scynexis trial; Incyte’s Zynyz notches another FDA approval
17 hours ago
News Briefing
Updated: Novo Nordisk CEO to step down amid stock decline, timeline for successor unknown
21 hours ago
People
Pharma
It's been three months without a biotech IPO
21 hours ago
Financing
Startups
Novo Nordisk’s global obesity leader is moving on; Flagship biotech gets CEO from Scholar Rock
21 hours ago
Peer Review
RFK Jr. adopts new chikungunya vaccine guidance; other recommendations remain under review
Yesterday
R&D
Pharma
'Go ahead and do it': Top RFK Jr. deputy dares drugmakers that might pull manufacturing over new price pressure
Yesterday
Pharma
Manufacturing
Regeneron scores $400M+ jury win in Amgen cholesterol drug spat
Yesterday
Pharma
Law
Eisai says Leqembi is headed for 'demand expansion phase' in US
Yesterday
Pharma
New CBER chief Prasad is readying 'massive framework' around vaccines, Makary says
Yesterday
Pharma
FDA+
Eli Lilly turns to South Korean RNA editing biotech for hearing loss in deal worth $1.3B
Yesterday
Startups
Deals
The inside story of the six-month sprint to create the first custom CRISPR therapy for one infant’s rare disease
Yesterday
R&D
Cell/Gene Tx
FDA warns Mayne Pharma over 'misleading' presentation slides on birth control pill
Yesterday
FDA+
Bristol Myers CEO says America’s biopharma pole position is not guaranteed
Yesterday
People
Pharma
Enliven stops work on solid tumor drug; Pulmatrix to divest assets
Yesterday
News Briefing
Pathos AI collects $365M to fuel 'bulletproof' oncology trials and in-license more cancer drugs
Yesterday
Financing
Startups
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