FDA+ channel feed – Endpoints News

FDA+ channel feed

Sarepta seeks to expand Duchenne gene therapy Elevidys use to toddlers

2 weeks ago

Deputy FDA chief mulls shaking up PDUFA reauthorization structure

2 weeks ago

FDA poses efficacy, safety questions over four cancer drugs ahead of two-day adcomm

2 weeks ago

RFK Jr. adopts new chikungunya vaccine guidance; other recommendations remain under review

3 weeks ago

New CBER chief Prasad is readying 'massive framework' around vaccines, Makary says

3 weeks ago

FDA warns Mayne Pharma over 'misleading' presentation slides on birth control pill

3 weeks ago

Biohaven stock sinks on three-month delay for neuro drug's FDA approval decision

3 weeks ago

RFK Jr. defends HHS staff cuts, reorganization plans in House, Senate hearings

3 weeks ago

RFK Jr. says his opinions of vaccines are ‘irrelevant.’ Former FDA chief Califf disagrees

3 weeks ago

FDA gives AbbVie accelerated approval for antibody-drug conjugate in lung cancer

3 weeks ago

GSK awaits Nucala decision after FDA target date passes

4 weeks ago

FDA grants Verastem first approval for rare ovarian cancer treatment

4 weeks ago

FDA will convene vaccine advisors to discuss Covid strain updates

4 weeks ago

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

4 weeks ago

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

4 weeks ago

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

4 weeks ago

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

4 weeks ago

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

4 weeks ago

New opioid data may not be generalizable, FDA adcomm says

4 weeks ago

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

4 weeks ago

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

4 weeks ago

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

4 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

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