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FDA approves subcutaneous Ocrevus, broadening access to Roche and Genentech blockbuster
8 months ago
Pharma
FDA+
WHO pre-qualifies Bavarian Nordic’s vaccine as first mpox shot
8 months ago
Pharma
Manufacturing
Online stimulant prescriptions soared during Covid pandemic, study finds
8 months ago
Pharma
Health Tech
Valneva raises about €61M; Immuneering details new Phase 2a data
8 months ago
News Briefing
Doug Williams returns with a ‘FIT’ bet on CAR-Ts; Biogen appoints Mene Pangalos to board
8 months ago
Peer Review
Oncternal stops cancer trials and begins search for future business options
8 months ago
R&D
Neurocrine culls Phase 2 neuropsych med after failing to validate earlier data
8 months ago
R&D
Bicara, Zenas and MBX rekindle IPO market with rare Friday tripleheader
8 months ago
Financing
Startups
Corrected: Roche’s Tecentriq scores first US approval for subcutaneous PD-L1
8 months ago
Pharma
FDA+
Seres' microbiome therapy reduces infections in stem cell transplant patients, but next steps are unclear
8 months ago
R&D
FDA revisits new structure for drug review documents, aiming to better explain its decisions
8 months ago
FDA+
Avadel's narcolepsy drug Lumryz misses PDUFA date, still under review at FDA
8 months ago
Pharma
FDA+
FDA should embrace new ways of evaluating rare disease drugs, report argues
8 months ago
Pharma
FDA+
Australian RNA manufacturer launches; Forge Biologics’ CEO steps down
8 months ago
Manufacturing
Debiopharm, ITM ink up to €300M licensing deal for cancer treatment
8 months ago
Deals
GSK’s mRNA flu shot is heading to Phase 3; Summit’s $235M offering
8 months ago
News Briefing
Fulcrum's Phase 3 for old GSK drug fails, stock sinks
8 months ago
R&D
Charles River to lay off 3% of staffers as it streamlines spending
8 months ago
People
Manufacturing
Sofinnova’s Jim Healy on ‘more rational market’ as four biotech startups near their IPOs
8 months ago
Financing
Startups
Lilly budgets $1.8B to boost Kisunla, GLP-1 manufacturing in Ireland
8 months ago
Manufacturing
Gilead says twice-yearly HIV prevention shot succeeds in second pivotal trial
8 months ago
R&D
Pharma
Noom offers compounded GLP-1 drugs, promises patients can quit and keep weight off
8 months ago
Pharma
Health Tech
A new startup wants to fight cancer with 'off-the-shelf' gene therapy, securing $26M seed round
8 months ago
Financing
Startups
F2G inks $100M Series H for another shot at treating fungal infections
8 months ago
Financing
Startups
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