FDA+ channel feed – Endpoints News

FDA+ channel feed

Makary, Prasad spell out FDA ground rules for future Covid vaccine approvals

4 weeks ago

Updated: FDA approves Novavax's Covid vaccine after six-week delay, but for a smaller population

4 weeks ago

Sarepta seeks to expand Duchenne gene therapy Elevidys use to toddlers

5 weeks ago

Deputy FDA chief mulls shaking up PDUFA reauthorization structure

5 weeks ago

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

5 weeks ago

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

5 weeks ago

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

5 weeks ago

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

5 weeks ago

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

Last month

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

Last month

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

Last month

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

Last month

GSK awaits Nucala decision after FDA target date passes

Last month

FDA grants Verastem first approval for rare ovarian cancer treatment

Last month

FDA will convene vaccine advisors to discuss Covid strain updates

Last month

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

Last month

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

Last month

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

Last month

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

Last month

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

Last month

New opioid data may not be generalizable, FDA adcomm says

Last month

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

Last month

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

Last month

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

Last month

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