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FDA+ channel feed
Marks was asked to provide non-existent vaccine risk data: WSJ
Last month
Novavax’s held-up approval package may signal warning for Covid vaccine makers
Last month
R&D
Pharma
Kennedy team defends Marks firing, while 20% of staff cuts may be 'mistakes'
Last month
Law
Senate confirms Dr. Oz to lead Medicare agency amid HHS overhaul
Last month
People
Pharma
FDA approves Amgen's Uplizna in IgG4-related disease
Last month
Pharma
Trump has touted Right to Try as a lifesaver. Several government staff supporting it were just let go
Last month
House and Senate committees call for briefings on health cuts from Kennedy
Last month
FDA will consolidate to five 'shared services offices,' according to memo to Hill staffers
Last month
Pharma
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
2 months ago
People
FDA sets new date for opioid-focused advisory meeting after earlier delay
2 months ago
Marks’ exit at FDA rattles an already teetering biotech industry
2 months ago
R&D
FDA's Peter Marks resigns, says he won't accept Kennedy's 'misinformation and lies'
2 months ago
At long last, Novartis’ radiopharma drug Pluvicto gets an expanded label
2 months ago
R&D
FDA approves Sanofi's RNAi drug for hemophilia A and B
2 months ago
R&D
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