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FDA+ channel feed
Post-Hoc: The big question for the FDA after Stealth’s PDUFA delay
3 weeks ago
Exclusive: After FDA firings, drug reviewers are asked to volunteer for administrative work
3 weeks ago
White House budget request would cut billions at NIH and CDC, add $500M for MAHA
3 weeks ago
Pharma
FDA withdraws two final guidances, pulls compliance deadlines for bone allograft makers
3 weeks ago
R&D
Pharma
Missing REMS delays Cytokinetics' heart drug PDUFA, stock drops
3 weeks ago
Pharma
FDA adcomms slated to review data on long-term opioid use, overdoses
3 weeks ago
Pharma
RFK Jr. claims placebo-controlled vaccine trials are 'radical departure' from past. Experts disagree
3 weeks ago
FDA approves Satsuma's migraine nasal spray after rejection in 2024
3 weeks ago
Pharma
Exits continue at FDA, as more staff in drug office follow fired colleagues out the door
3 weeks ago
People
FDA approves J&J's rare disease drug that's expected to compete with argenx and UCB
3 weeks ago
Pharma
FDA approves Abeona’s skin disease cell therapy
3 weeks ago
Pharma
Cell/Gene Tx
FDA won't reorganize medical product centers, Makary says in interview: 'I rejected that proposal'
3 weeks ago
FDA delays PDUFA date for small biotech, raising questions about impact of agency cuts
3 weeks ago
Vaxart says it can resume next-gen Covid work, will screen participants for oral vaccine trial
4 weeks ago
Pharma
Coronavirus
Novavax responds to FDA’s trial ask, with Covid vaccine strain updates under scrutiny
4 weeks ago
Pharma
Coronavirus
European regulators recommend new drugs from Vertex, Amgen and Jazz
4 weeks ago
Pharma
FDA chief Makary talks expediting drug approvals, RIFs and the abortion pill
4 weeks ago
R&D
Pharma
Only two-thirds of FDA-approved biosimilars have launched, report finds
4 weeks ago
Pharma
Cassidy urges congressional reforms to 340B drug discount program after investigation
4 weeks ago
Pharma
Large vaccine makers stand by their investments despite US headwinds
4 weeks ago
Pharma
Top pharma companies increased lobbying spend in first quarter of 2025
4 weeks ago
Pharma
Law
FDA asks Novavax for post-marketing data of its Covid vaccine, delaying approval
4 weeks ago
Pharma
Coronavirus
Recent FDA staff cuts to delay drug hearing decision by months, agency tells Vanda
4 weeks ago
Law
FDA plans to ban pharma employees from serving on adcomms. The impact will be limited
5 weeks ago
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