FDA+ channel feed – Endpoints News

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

FDA withdraws two final guidances, pulls compliance deadlines for bone allograft makers

3 weeks ago

Missing REMS delays Cytokinetics' heart drug PDUFA, stock drops

3 weeks ago

FDA adcomms slated to review data on long-term opioid use, overdoses

3 weeks ago

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

Exits continue at FDA, as more staff in drug office follow fired colleagues out the door

3 weeks ago

FDA approves J&J's rare disease drug that's expected to compete with argenx and UCB

3 weeks ago

FDA approves Abeona’s skin disease cell therapy

3 weeks ago

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

Novavax responds to FDA’s trial ask, with Covid vaccine strain updates under scrutiny

4 weeks ago

European regulators recommend new drugs from Vertex, Amgen and Jazz

4 weeks ago

FDA chief Makary talks expediting drug approvals, RIFs and the abortion pill

4 weeks ago

Only two-thirds of FDA-approved biosimilars have launched, report finds

4 weeks ago

Cassidy urges congressional reforms to 340B drug discount program after investigation

4 weeks ago

Large vaccine makers stand by their investments despite US headwinds

4 weeks ago

Top pharma companies increased lobbying spend in first quarter of 2025

4 weeks ago

FDA asks Novavax for post-marketing data of its Covid vaccine, delaying approval

4 weeks ago

Recent FDA staff cuts to delay drug hearing decision by months, agency tells Vanda

4 weeks ago

FDA plans to ban pharma employees from serving on adcomms. The impact will be limited

5 weeks ago

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