FDA+ channel feed – Endpoints News

FDA+ channel feed

Recall report: Another drugmaker is pulling its version of metformin off shelves after a carcinogen scare

4 years ago

A snakebit biotech receives second CRL for reformulated pain med, potentially putting the kibosh on its chances

4 years ago

75M vaccine doses wasted: FDA spells out Emergent facility deficiencies at length in new memo

4 years ago

FDA authorizes about 10M J&J vaccine doses, trashes 60M more from troubled Emergent plant

4 years ago

An expensive watch, shell companies and fake invoices: How two Israeli traders tapped into a $100M global biotech insider trading ring

4 years ago

Harvard’s Aaron Kesselheim resigns from expert panel in wake of aducanumab OK, blasting FDA for ‘worst drug approval decision in recent U.S. history'

4 years ago

A second adcomm member abandons his post in aftermath of controversial aducanumab decision

4 years ago

FDA plans new studies on accelerated approval disclosures in biopharma ads

4 years ago

UPDATE: Will Biogen ever publish the trial results for its new Alzheimer’s drug?

4 years ago

FDA dips its toe into the world of patient-reported outcomes for cancer trials

4 years ago

Pfizer rolls out next-gen pneumococcal vaccine with FDA win, beating Merck's 15-valent candidate to the punch

4 years ago

Adcomm member who warned about risk of approving Biogen's aducanumab has resigned following historic OK — reports

4 years ago

Covid-19 vaccines for kids: FDA spells out questions on immunobridging, safety followup ahead of adcomm

4 years ago

FDA rejects Google's push to add virtual exam for Parkinson’s disease to its smartwatch

4 years ago

White House lays out sprawling new plan to shore up pharma and API manufacturing

4 years ago

Opinion: How the FDA bent its rules for Biogen’s Alzheimer’s drug and why that’s bad for the entire biopharma industry

4 years ago

FDA OKs aducanumab for Alzheimer's, turning controversial Biogen drug into a megablockbuster

4 years ago

Novo Nordisk scores a win for semaglutide in obesity, potentially setting up a next-gen battle with Eli Lilly

4 years ago

Regeneron continues reign atop the Covid treatment field with expanded EUA for lower dose subcutaneous version of mAb cocktail

4 years ago

Biopharma supply chain security: FDA guidance spells out new expectations

4 years ago

Amryt earns a priority review in a rare disease that makes patients' skin fragile as butterfly wings

4 years ago

Former FDA No. 2 Amy Abernethy rejoins Robert Califf at Google's Verily, hopping aboard as clinical R&D head

4 years ago

Scynexis will pit a new class of antifungals against yeast infections — and it won't come cheap

4 years ago

Appeals court sides with FDA in lawsuit over fat-derived stem cell procedure

4 years ago

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