FDA+ channel feed – Endpoints News

FDA+ channel feed

FDA offers support for Pfizer, Moderna Covid-19 vaccines for the youngest children ahead of adcomm

3 years ago

Amylyx picks up ALS drug approval in Canada after FDA asks for more time to review the data

3 years ago

Bluebird goes 2-for-2 on gene therapies at FDA adcomm with thumbs up for beti-cel

3 years ago

Ahead of accelerated approval withdrawal hearing, Covis asks FDA to omit study potentially linking Makena and cancer

3 years ago

In surprise, FDA adcomm votes unanimously in favor of bluebird's gene therapy for rare disease even with safety concerns

3 years ago

House passes bipartisan FDA user fee legislation as it aligns with Senate on accelerated approval reforms

3 years ago

EMA to keep closer tabs on supplies of all approved Covid-19 vaccines and therapeutics

3 years ago

FDA advisors vote 21-0, with one abstention, to authorize Novavax’s Covid-19 vaccine to be the fourth US option

3 years ago

Ahead of 2-day adcomm, FDA sounds positive on one bluebird gene therapy but questions remain for another

3 years ago

FDA slams small pharma for misleading ad with a dearth of safety info and dubious stat calculations

3 years ago

DC appeals court quashes Nostrum's suit against FDA, explaining CRLs are not final rejections

3 years ago

Bristol Myers pulls plug on Reblozyl program for rare blood disorder, months after missed PDUFA date

3 years ago

FDA shines light on Indian manufacturer’s misgivings at one of its facilities

3 years ago

FDA approves GSK's MMR vaccine, the first new green light in more than half a century

3 years ago

FDA review spotlights risk of heart inflammation linked to Novavax's Covid vaccine — shares tumble

3 years ago

Amylyx's ALS drug gets a three-month PDUFA delay, setting up the pivotal decision for September

3 years ago

Another refuse-to-file for a small biotech — is the FDA using RTFs to manage its workload?

3 years ago

FDA compliance vet heads to India-based Lupin after long public career

3 years ago

FDA+ roundup: Medicare spends billions on unconfirmed accelerated approvals — study; EMA appoints new CMO

3 years ago

FDA's Peter Marks lays out plans to support gene therapies for ultra-rare diseases

3 years ago

FDA lifts hold on Legend Biotech's follow-up CAR-T targeting CD4+

3 years ago

FDA cites increased death risk in decision to yank approval for TG Therapeutics cancer drug

3 years ago

Sanofi earns breakthrough nod in hemophilia A as it continues to play catch-up with Roche's Hemlibra

3 years ago

Another 14 generics threaten Eli Lilly's blockbuster chemotherapy Alimta

3 years ago

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