FDA+ channel feed – Endpoints News

FDA+ channel feed

Seagen secures a speedy FDA review on Tukysa as Merck buyout talks reportedly stall

3 years ago

Bluebird lands another rare disease gene therapy OK — but there are a few caveats to note

3 years ago

Vanda sues FDA yet again, accuses federal agency of delaying post-CRL hearing

3 years ago

Novartis files another FDA petition to halt Entresto competition as blockbuster fight approaches

3 years ago

FDA unveils list of alternative ways to comply with cGMP requirements for combo products

3 years ago

Crunch time for FDA user fees as reauthorization looks to hitch a ride on short-term spending bill

3 years ago

Retiring Republican senator lambasts Biden appointees' response to monkeypox outbreak

3 years ago

Still leery about animal deaths, FDA lifts a full hold on Friedreich’s ataxia drug — but there’s a big condition

3 years ago

Government-paid experts helping industry at the table with FDA? Agency spells out guardrails

3 years ago

New generics save patients billions per year, according to FDA report

3 years ago

Form 483 unmasks manufacturing issues at Alvotech before its CRL, and one for Aurobindo too

3 years ago

Biotech-backed nonprofit joins with FDA to standardize process for submitting in vitro pharmacology data

3 years ago

'Really include everyone in the trial': A Q&A with the protocol chair of the PhIII monkeypox antiviral study

3 years ago

Implementing 'Right-to-Try': FDA signals likelihood of only minimal manufacturer participation

3 years ago

FDA schedules joint advisory committee meeting to consider first over-the-counter birth control pill

3 years ago

BioMarin says PhIII gene therapy study participant's cancer is unrelated to therapy

3 years ago

FDA hires new vaccine director, a year after two senior leaders quit in protest

3 years ago

Biden turns to biotech for his inaugural ARPA-H director

3 years ago

Manufacturers sound off on FDA drug reporting guidance, pointing to challenges and recommendations

3 years ago

Colorado to seek FDA approval by fall on Canadian drug imports

3 years ago

Amgen's Neulasta gains another biosimilar competitor as sales slip

3 years ago

Adcomm votes 7-2 in favor of Amylyx's ALS drug on second take. But first the co-CEOs had to make a pledge

3 years ago

On the heels of unprompted EMA review of Covid drug, FDA schedules adcomm for potential EUA

3 years ago

Form 483 reveals spore contamination at a South Korean manufacturing site last year

3 years ago

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