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FDA+ channel feed
‘It’ll be a challenge’: BIO chief Crowley addresses seismic FDA overhaul
3 months ago
People
Pharma
RFK Jr. has long criticized drug ads. He just slashed the FDA office that regulates them
3 months ago
Pharma
Marketing
European drug regulator seeks to ‘streamline’ biosimilar approval process
3 months ago
Pharma
Firings sweep across FDA as former leaders lament the gutting of drug agency
3 months ago
People
What’s next after Marks? At FDA, questions over more top exits and future vision for drug agency
3 months ago
People
FDA sets new date for opioid-focused advisory meeting after earlier delay
3 months ago
Marks’ exit at FDA rattles an already teetering biotech industry
3 months ago
R&D
FDA's Peter Marks resigns, says he won't accept Kennedy's 'misinformation and lies'
3 months ago
At long last, Novartis’ radiopharma drug Pluvicto gets an expanded label
3 months ago
R&D
FDA approves Sanofi's RNAi drug for hemophilia A and B
3 months ago
R&D
CHMP recommends seven label expansions and one new approval, rejects Lilly Alzheimer's drug
3 months ago
Pharma
European regulator rejects Lilly's Alzheimer’s drug over potentially fatal side effects
3 months ago
Pharma
FDA’s policy, communications staff likely to be among agency’s 3,500 staff cuts
3 months ago
Law
Kennedy announces 10,000 job cuts at HHS, with major reductions expected at FDA, NIH and CDC
3 months ago
Pharma
FDA approves first drug for Prader-Willi syndrome, to tamp down insatiable hunger symptoms
3 months ago
R&D
FDA critiques Taiho Oncology's 'misleading' promotional website for bile duct cancer drug
3 months ago
Senate confirms Makary as FDA chief with agency cuts, return-to-office in force
3 months ago
R&D
Pharma
Covid contrarian Bhattacharya is confirmed as NIH chief, taking over at a fraught moment for federal research
3 months ago
People
DOGE pulls three FDA lease closures from 'Wall of Receipts,' including St. Louis quality lab
3 months ago
GSK scores FDA approval for antibiotic to treat uncomplicated UTIs
3 months ago
Pharma
Trump taps acting CDC chief Susan Monarez for permanent role
3 months ago
People
FDA's biologics chief stresses need for vaccine transmission data despite high costs to generate
3 months ago
R&D
Liver cancer drug combo gets second FDA rejection over manufacturing issues
3 months ago
Pharma
Manufacturing
Alnylam hopes its broad ATTR-CM label can give Amvuttra an edge in heart disease
3 months ago
Pharma
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