FDA+ channel feed – Endpoints News

FDA+ channel feed

Sarepta’s stock plummets after Prasad appointment, low Elevidys sales

2 months ago

Trump, FDA zero in on foreign factories to give domestic sites an edge

2 months ago

FDA picks controversial doctor Vinay Prasad as CBER director, in about-face from Marks

2 months ago

New opioid data may not be generalizable, FDA adcomm says

2 months ago

FDA adcomm will review Capricor's cell therapy for Duchenne muscular dystrophy

2 months ago

Even as questions grow over RFK Jr.'s vaccine policy, BioNTech doesn't see ‘near-term’ impact

2 months ago

Post-Hoc: The big question for the FDA after Stealth’s PDUFA delay

2 months ago

Exclusive: After FDA firings, drug reviewers are asked to volunteer for administrative work

2 months ago

White House budget request would cut billions at NIH and CDC, add $500M for MAHA

2 months ago

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

2 months ago

Missing REMS delays Cytokinetics' heart drug PDUFA, stock drops

2 months ago

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

2 months ago

RFK Jr. claims placebo-controlled vaccine trials are 'radical departure' from past. Experts disagree

2 months ago

FDA approves Satsuma's migraine nasal spray after rejection in 2024

2 months ago

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

2 months ago

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

2 months ago

FDA approves Abeona’s skin disease cell therapy

2 months ago

FDA won't reorganize medical product centers, Makary says in interview: 'I rejected that proposal'

2 months ago

FDA delays PDUFA date for small biotech, raising questions about impact of agency cuts

2 months ago

Vaxart says it can resume next-gen Covid work, will screen participants for oral vaccine trial

2 months ago

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

2 months ago

European regulators recommend new drugs from Vertex, Amgen and Jazz

2 months ago

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

2 months ago

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

2 months ago

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