FDA+ channel feed – Endpoints News

FDA+ channel feed

FDA adcomm votes unanimously against Pfizer's prostate cancer drug combo

Last month

FDA asks Covid vaccine makers to add more myocarditis data to labels

Last month

FDA announces efforts to facilitate drug importation from Canada

Last month

FDA adcomm narrowly votes against UroGen’s bladder cancer drug, calls for RCTs

Last month

In his first major policy rollout, Vinay Prasad looks to challenge existing 'dogma' on Covid vaccines

Last month

Updated: FDA adcomm splits votes on Genentech and J&J cancer drugs

Last month

RFK Jr. spars with senators over research cuts, HHS budget plan

Last month

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

Last month

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

Last month

Sarepta seeks to expand Duchenne gene therapy Elevidys use to toddlers

Last month

Deputy FDA chief mulls shaking up PDUFA reauthorization structure

Last month

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

Last month

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

Last month

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

Last month

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

Last month

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

2 months ago

FDA grants Verastem first approval for rare ovarian cancer treatment

2 months ago

FDA will convene vaccine advisors to discuss Covid strain updates

2 months ago

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

2 months ago

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

2 months ago

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