FDA+ channel feed – Endpoints News

FDA+ channel feed

J&J scores approval for Rybrevant combo in first-line lung cancer, stoking rivalry with Tagrisso

8 months ago

FTC backs FDA plan to remove switching study requirement for interchangeable biosimilars

8 months ago

House lawmakers call on FDA to investigate clinical trials run alongside China's military

8 months ago

Liquidia scores only tentative approval for Yutrepia due to Tyvaso exclusivity

8 months ago

FDA approves AstraZeneca’s Imfinzi before and after lung cancer surgery

8 months ago

Updated: Lykos cutting most of staff less than a week after FDA rejection

8 months ago

Updated: Federal government reveals negotiated prices under Inflation Reduction Act

8 months ago

Biden administration says IRA negotiations will result in $6B in 2026 Medicare savings

8 months ago

Incyte gets another graft-versus-host disease drug approval, this time with partner Syndax

8 months ago

FDA warning letter targets doctor who worked on a Takeda Phase 3 study

8 months ago

Gilead wins FDA accelerated approval of seladelpar after acquiring it in $4.3B deal

8 months ago

Past and present FDA adcomm members weigh in on potential reforms

8 months ago

Federal judge rules against Novartis in Entresto generic lawsuit

8 months ago

Galderma wins FDA approval for IL-31 drug in chronic skin disease

8 months ago

Lawmakers renew calls for government to finalize march-in guidance

9 months ago

Corrected: Novo Nordisk to file in EU and China with late-phase insulin plus semaglutide data – but not yet in the US

9 months ago

Three papers on MDMA are retracted by medical journal, just a day after Lykos' FDA rejection

9 months ago

Ascendis scores FDA approval for hypoparathyroidism candidate to replace Takeda's pulled drug

9 months ago

FDA delays approval decision on Humacyte’s lab-grown blood vessels

9 months ago

Lykos’ MDMA-assisted PTSD treatment rejected by FDA after troubled trial and pushback from experts

9 months ago

Hello, neffy: FDA approves first nasal spray for severe allergic reactions

9 months ago

Genentech, Gilead push FDA to modernize research inspections

9 months ago

Alfasigma's PBC treatment Ocaliva to face an FDA adcomm in September

9 months ago

FDA lifts hold on 4DMT's Fabry gene therapy

9 months ago

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