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FDA+ channel feed
FDA approves Dupixent for hives, rejects new Eylea dosing schedule
4 weeks ago
GSK kicks off Blenrep relaunch plans with clearance from UK regulators
Last month
Pharma
CMS would absorb 340B drug discount program under leaked HHS reorganization proposal
Last month
Pharma
Pharma's wins and losses in Trump's sprawling executive order on drug prices
Last month
Pharma
Law
At ACIP hearing, CDC says it's 'scraping' to respond to measles outbreak; FDA comments on Novavax halt
Last month
Pharma
Click gets FDA authorization for preventive migraine digital therapeutic
Last month
Health Tech
Leqembi wins EU authorization for some Alzheimer's patients, giving Biogen, Eisai a boost over Lilly
Last month
Pharma
CDC vaccine advisors are set to meet this week after two-month delay and scrutiny from Kennedy
Last month
R&D
Pharma
AbbVie and Sandoz agree to drop court spat over Rinvoq patents
Last month
Pharma
FDA's union readies negotiations with HHS over some fired staff
Last month
Sandoz sues Amgen over nine-year launch delay for Enbrel biosimilar
Last month
Pharma
Law
Ironwood to look for alternative paths after FDA asks for another Phase 3
Last month
Pharma
Makary wants to replace animal testing with organoids. It may take a while
Last month
R&D
Bristol Myers' immunotherapy combo nets approvals in colorectal and liver cancer
Last month
R&D
CDMOs anticipate inspection bottlenecks after mass FDA firings
Last month
Manufacturing
FDA quietly begins reversing return-to-office mandate for some workers
Last month
Biotech CEOs to Cassidy: We're already seeing the effects of FDA's staff cuts
Last month
Pharma
Firings of HHS' probationary workers can proceed, appeals court says
Last month
Law
Drug pricing watchdog ICER offers ways to increase obesity drug access
Last month
Pharma
House panel mulls ways to boost struggling US biosimilar market
Last month
Law
Could Kennedy's FDA cuts trigger an obscure clawback provision for industry user fees?
Last month
Law
Rare disease hub at CDER and CBER faces new reality with staff crunch
Last month
Pharma
‘This is self-inflicted’: Leerink’s David Risinger on the market shock and hits to biopharma
Last month
People
RFK Jr. won’t testify before key Senate committee this week on HHS overhaul
Last month
Pharma
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