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GSK awaits Nucala decision after FDA target date passes

8 hours ago

FDA grants Verastem first approval for rare ovarian cancer treatment

9 hours ago

FDA will convene vaccine advisors to discuss Covid strain updates

Yesterday

FDA's ODAC will review drugs for four different cancers at meeting in May

Yesterday

What Vinay Prasad means for CBER, vaccines, drug approvals and more

Yesterday

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

2 days ago

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

2 days ago

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

2 days ago

New opioid data may not be generalizable, FDA adcomm says

3 days ago

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

3 days ago

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

3 days ago

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

3 days ago

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

6 days ago

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

6 days ago

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

6 days ago

Missing REMS delays Cytokinetics' heart drug PDUFA, stock drops

6 days ago

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

Last week

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

Last week

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

Last week

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

Last week

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

Last week

FDA approves Abeona’s skin disease cell therapy

Last week

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

Last week

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

Last week

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