FDA+ channel feed – Endpoints News

FDA+ channel feed

FDA greenlights updated Covid shots, making fall booster rollout imminent

Last year

FDA maintains Covid flexibilities for IRB review of expanded access drugs for individuals

Last year

Expedited CMC readiness pilot increases communications between FDA and sponsors

Last year

Citius Pharmaceuticals looks to refile former Eisai cancer drug in early 2024

Last year

Medicare enrollees paid far more for drugs than plan sponsors did in 2021, GAO says

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Bipartisan House group calls on FDA to ensure OTC and prescription versions of a drug cannot be marketed simultaneously

Last year

Merck to face FDA adcomm in November over previously rejected potential chronic cough drug

Last year

FDA approves first generics for Takeda’s Vyvanse as ADHD drug shortages persist

Last year

Amid aprocitentan’s regulatory review, Idorsia is buying back the hypertension drug from J&J in $350M deal

Last year

AstraZeneca’s Ultomiris label expansion stalls after FDA rejects sBLA, asks for REMS changes

Last year

FDA tentatively approves generic version of pediatric HIV drug under PEPFAR program

Last year

'FDA is not a physician,' appeals court rules in case against agency's ivermectin messaging

Last year

Illinois college of pharmacy petitions FDA to remove clinical requirements for biosimilars

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FDA offers clarity on post-warning letter meetings in new draft guidance

Last year

EMA safety committee ramps up warning against use of topiramate during pregnancy

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Lilly, Novo, Sanofi face pressure from lawmakers to clarify low-cost insulin programs

Last year

FDA aims to better incentivize quality drug manufacturing in new program

Last year

Botulism risk: FDA delivers warning letter to Gadal Labs for site making OTC pediatric drugs

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Democrat lawmakers call on FDA to take steps to prevent misuse of Orange Book

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FDA+ roundup: FDA issues final guidance on use of real-world evidence

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FDA rejected Outlook Therapeutics' Lucentis rival, and the company's stock plunged

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After delay, Abeona aims for fall FDA submission for rare skin condition cell therapy

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Eye drop producer KC Pharmaceuticals receives FDA warning letter

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Bristol Myers secures FDA label expansion for anemia drug Reblozyl

Last year

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