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FDA+ channel feed
RFK Jr. says his opinions of vaccines are ‘irrelevant.’ Former FDA chief Califf disagrees
Last week
Pharma
FDA gives AbbVie accelerated approval for antibody-drug conjugate in lung cancer
Last week
Pharma
GSK awaits Nucala decision after FDA target date passes
3 weeks ago
Pharma
FDA grants Verastem first approval for rare ovarian cancer treatment
3 weeks ago
Pharma
FDA will convene vaccine advisors to discuss Covid strain updates
3 weeks ago
Pharma
FDA's ODAC will review drugs for four different cancers at meeting in May
3 weeks ago
Pharma
What Vinay Prasad means for CBER, vaccines, drug approvals and more
3 weeks ago
Pharma
Sarepta’s stock plummets after Prasad appointment, low Elevidys sales
3 weeks ago
Pharma
Trump, FDA zero in on foreign factories to give domestic sites an edge
3 weeks ago
Pharma
Manufacturing
FDA picks controversial doctor Vinay Prasad as CBER director, in about-face from Marks
3 weeks ago
New opioid data may not be generalizable, FDA adcomm says
3 weeks ago
Pharma
FDA adcomm will review Capricor's cell therapy for Duchenne muscular dystrophy
3 weeks ago
Pharma
Cell/Gene Tx
Even as questions grow over RFK Jr.'s vaccine policy, BioNTech doesn't see ‘near-term’ impact
3 weeks ago
R&D
Pharma
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
4 weeks ago
White House budget request would cut billions at NIH and CDC, add $500M for MAHA
4 weeks ago
Pharma
FDA withdraws two final guidances, pulls compliance deadlines for bone allograft makers
4 weeks ago
R&D
Pharma
Missing REMS delays Cytokinetics' heart drug PDUFA, stock drops
4 weeks ago
Pharma
FDA adcomms slated to review data on long-term opioid use, overdoses
4 weeks ago
Pharma
RFK Jr. claims placebo-controlled vaccine trials are 'radical departure' from past. Experts disagree
4 weeks ago
FDA approves Satsuma's migraine nasal spray after rejection in 2024
4 weeks ago
Pharma
Exits continue at FDA, as more staff in drug office follow fired colleagues out the door
4 weeks ago
People
FDA approves J&J's rare disease drug that's expected to compete with argenx and UCB
4 weeks ago
Pharma
FDA approves Abeona’s skin disease cell therapy
4 weeks ago
Pharma
Cell/Gene Tx
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