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Judge tosses Amgen's challenge to Colorado drug review board, says suit is 'too speculative'
2 months ago
Pharma
Law
At long last, Novartis’ radiopharma drug Pluvicto gets an expanded label
2 months ago
R&D
FDA+
FDA approves Sanofi's RNAi drug for hemophilia A and B
2 months ago
R&D
FDA+
J&J beats Viatris in patent fight over its antipsychotic drug, staving off competition
2 months ago
Pharma
Law
CHMP recommends seven label expansions and one new approval, rejects Lilly Alzheimer's drug
2 months ago
Pharma
FDA+
Milestone's shares dive after FDA again rejects drug for abnormal heart rhythm
2 months ago
Pharma
Manufacturing
DBV’s financing for peanut allergy patch; Eisai divests proton pump inhibitor in China
2 months ago
News Briefing
European regulator rejects Lilly's Alzheimer’s drug over potentially fatal side effects
2 months ago
Pharma
FDA+
BioNTech details promising mid-stage data for its PD-L1xVEGF in aggressive lung cancer
2 months ago
R&D
Novo inks second obesity deal of the week, with Lexicon oral drug partnership worth up to $1B
2 months ago
Deals
Pharma
On the heels of staff cuts, CRISPR Therapeutics COO departs; Changes galore at Bicycle
2 months ago
Peer Review
Before Alumis went public via IPO, it tried doing a reverse merger with Acelyrin
2 months ago
Deals
Merck KGaA pays Abbisko $85M for full commercial rights to benign tumor drug
2 months ago
Deals
R&D
FDA’s policy, communications staff likely to be among agency’s 3,500 staff cuts
2 months ago
FDA+
Law
Merck details injectable Keytruda data as it awaits autumn FDA decision
2 months ago
R&D
Exclusive: Metsera CEO on what it takes to build an obesity biotech in 2025
2 months ago
Startups
Pharma
With tariffs on the way, generic drugmaking woes could hinder Trump’s reshoring plan
2 months ago
Pharma
Manufacturing
Chiesi pours €430 into new Italy site; Bharat’s first CGT site in India
2 months ago
Manufacturing
Equillium says graft-versus-host drug fails Phase 3, stock dives
2 months ago
R&D
What happened to Miga Health
2 months ago
Health Tech
Nkarta to lay off 34% of staff; Savara’s debt financing deal
2 months ago
News Briefing
Kennedy announces 10,000 job cuts at HHS, with major reductions expected at FDA, NIH and CDC
2 months ago
Pharma
FDA+
Why Miga Health's co-founders decided to quit building
2 months ago
Deals
Health Tech
Financial returns and efficiency of AI scribes remain unclear, report finds
2 months ago
AI
Health Tech
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