FDA+ channel feed – Endpoints News

FDA+ channel feed

Marks’ exit at FDA rattles an already teetering biotech industry

2 months ago

FDA's Peter Marks resigns, says he won't accept Kennedy's 'misinformation and lies'

2 months ago

At long last, Novartis’ radiopharma drug Pluvicto gets an expanded label

2 months ago

FDA approves Sanofi's RNAi drug for hemophilia A and B

2 months ago

CHMP recommends seven label expansions and one new approval, rejects Lilly Alzheimer's drug

2 months ago

European regulator rejects Lilly's Alzheimer’s drug over potentially fatal side effects

2 months ago

FDA’s policy, communications staff likely to be among agency’s 3,500 staff cuts

2 months ago

Kennedy announces 10,000 job cuts at HHS, with major reductions expected at FDA, NIH and CDC

2 months ago

FDA approves first drug for Prader-Willi syndrome, to tamp down insatiable hunger symptoms

2 months ago

FDA critiques Taiho Oncology's 'misleading' promotional website for bile duct cancer drug

2 months ago

Senate confirms Makary as FDA chief with agency cuts, return-to-office in force

2 months ago

Covid contrarian Bhattacharya is confirmed as NIH chief, taking over at a fraught moment for federal research

2 months ago

DOGE pulls three FDA lease closures from 'Wall of Receipts,' including St. Louis quality lab

2 months ago

GSK scores FDA approval for antibiotic to treat uncomplicated UTIs

2 months ago

Trump taps acting CDC chief Susan Monarez for permanent role

2 months ago

FDA's biologics chief stresses need for vaccine transmission data despite high costs to generate

2 months ago

Liver cancer drug combo gets second FDA rejection over manufacturing issues

2 months ago

Alnylam hopes its broad ATTR-CM label can give Amvuttra an edge in heart disease

2 months ago

BARDA cancels annual biomedical event for industry, government reps

2 months ago

FDA approves Novartis’ Fabhalta in another rare kidney disease

2 months ago

Updated: FDA approves Alnylam’s Amvuttra in ATTR-CM, kicking off competition with Pfizer, BridgeBio

2 months ago

Akero exec calls FDA's accelerated approval guidance for MASH drugs 'bizarre'

2 months ago

Two-thirds of recent rare disease drugs relied on just one trial, plus confirmatory evidence, FDA team finds

2 months ago

DOJ lawyers defend abortion pill restrictions in new court filing

2 months ago

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