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FDA+ channel feed
Aldeyra gets another CRL for its dry eye disease drug that AbbVie has the option to co-develop
Last month
Pharma
Trump’s broad tariffs exempt pharma — but for how long?
Last month
Pharma
Manufacturing
FDA cuts stir buyer’s remorse for some biopharma leaders, once excited by Trump
Last month
Pharma
Cell/Gene Tx
Day after mass FDA firings, new commissioner addresses remaining staff, focusing on 'MAHA' vision
Last month
Q&A: John Crowley warns biotech is 'dangerously close' to breaking, as tariff threat, markets batter industry
Last month
People
Pharma
Judge orders HHS, other agencies to 'undo' probationary worker firings
Last month
Pharma
‘It’ll be a challenge’: BIO chief Crowley addresses seismic FDA overhaul
Last month
People
Pharma
RFK Jr. has long criticized drug ads. He just slashed the FDA office that regulates them
Last month
Pharma
Marketing
European drug regulator seeks to ‘streamline’ biosimilar approval process
Last month
Pharma
Firings sweep across FDA as former leaders lament the gutting of drug agency
Last month
People
What’s next after Marks? At FDA, questions over more top exits and future vision for drug agency
Last month
People
FDA sets new date for opioid-focused advisory meeting after earlier delay
Last month
Marks’ exit at FDA rattles an already teetering biotech industry
Last month
R&D
FDA's Peter Marks resigns, says he won't accept Kennedy's 'misinformation and lies'
Last month
At long last, Novartis’ radiopharma drug Pluvicto gets an expanded label
Last month
R&D
FDA approves Sanofi's RNAi drug for hemophilia A and B
Last month
R&D
CHMP recommends seven label expansions and one new approval, rejects Lilly Alzheimer's drug
Last month
Pharma
European regulator rejects Lilly's Alzheimer’s drug over potentially fatal side effects
Last month
Pharma
FDA’s policy, communications staff likely to be among agency’s 3,500 staff cuts
Last month
Law
Kennedy announces 10,000 job cuts at HHS, with major reductions expected at FDA, NIH and CDC
Last month
Pharma
FDA approves first drug for Prader-Willi syndrome, to tamp down insatiable hunger symptoms
Last month
R&D
FDA critiques Taiho Oncology's 'misleading' promotional website for bile duct cancer drug
Last month
Senate confirms Makary as FDA chief with agency cuts, return-to-office in force
2 months ago
R&D
Pharma
Covid contrarian Bhattacharya is confirmed as NIH chief, taking over at a fraught moment for federal research
2 months ago
People
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