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FDA+ channel feed
Sarepta’s stock plummets after Prasad appointment, low Elevidys sales
2 months ago
Pharma
Trump, FDA zero in on foreign factories to give domestic sites an edge
2 months ago
Pharma
Manufacturing
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
Pharma
FDA adcomm will review Capricor's cell therapy for Duchenne muscular dystrophy
2 months ago
Pharma
Cell/Gene Tx
Even as questions grow over RFK Jr.'s vaccine policy, BioNTech doesn't see ‘near-term’ impact
2 months ago
R&D
Pharma
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
Pharma
FDA withdraws two final guidances, pulls compliance deadlines for bone allograft makers
2 months ago
R&D
Pharma
Missing REMS delays Cytokinetics' heart drug PDUFA, stock drops
2 months ago
Pharma
FDA adcomms slated to review data on long-term opioid use, overdoses
2 months ago
Pharma
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
Pharma
Exits continue at FDA, as more staff in drug office follow fired colleagues out the door
2 months ago
People
FDA approves J&J's rare disease drug that's expected to compete with argenx and UCB
2 months ago
Pharma
FDA approves Abeona’s skin disease cell therapy
2 months ago
Pharma
Cell/Gene Tx
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
Pharma
Coronavirus
Novavax responds to FDA’s trial ask, with Covid vaccine strain updates under scrutiny
2 months ago
Pharma
Coronavirus
European regulators recommend new drugs from Vertex, Amgen and Jazz
2 months ago
Pharma
FDA chief Makary talks expediting drug approvals, RIFs and the abortion pill
2 months ago
R&D
Pharma
Only two-thirds of FDA-approved biosimilars have launched, report finds
2 months ago
Pharma
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