FDA+ channel feed – Endpoints News

FDA+ channel feed

A $3B+ peak sales win? Pfizer thinks so, as FDA offers a tardy green light to its JAK1 drug abrocitinib

4 years ago

Europe preps for the launch of its new clinical trials database, with a push to increase trial participation

4 years ago

Rob Califf advances as Biden's FDA nominee, with a close committee vote

4 years ago

CRO owner pleads guilty to obstructing FDA investigation into falsified clinical trial data

4 years ago

Woodcock defends FDA's response to Omicron before Senate health committee

4 years ago

FDA approves potential blockbuster insomnia drug, a first for Swiss biotech Idorsia

4 years ago

FDA loses FOIA suit over Pfizer vaccine documents, must release 55,000 pages per month

4 years ago

Pfizer and other biopharmas to FDA: Don't include CMOs in new reporting requirements on drug volume

4 years ago

FDA+ roundup: Agency restructures chief scientist's office; First vote on Rob Califf as commissioner pushed to next week

4 years ago

FDA pauses domestic drug inspections again, this time to protect against Omicron

4 years ago

Biotech pulls plans to file accelerated approval after FDA 'change in direction' — shares plummet

4 years ago

FDA adds another drug OK to cap a record win list for 2021

4 years ago

Hitting a new record on drug approvals, the FDA offers a thumbs-up to another atopic dermatitis contender

4 years ago

FDA authorizes new Merck Covid-19 pill despite scientists' concerns on its mechanism of action

4 years ago

It's a year late, but Novartis has finally steered inclisiran to FDA approval. Will it sell?

4 years ago

FDA authorizes the first at-home pills from Pfizer to treat Covid-19

4 years ago

Months after missing its PDUFA date, FDA slaps down Takeda's old Shire drug for eosinophilic esophagitis

4 years ago

FDA slaps a hold on Gilead's injectable HIV treatment over concerns about potential glass contaminants

4 years ago

FDA slams clinical hold on tiny psychedelics player's shot at bringing LSD-assisted therapy to more patients

4 years ago

Alzheimer's experts call on FDA to pull Biogen's Aduhelm

4 years ago

With few treatment options for Omicron, convalescent plasma is ready for a comeback — will the FDA be on board with outpatient use?

4 years ago

FDA clears first long-acting HIV-prevention injectable, giving ViiV claim to historic OK

4 years ago

Aldeyra shares spiral after a late-stage failure in dry eye disease — but that won't stop its pursuit of an NDA

4 years ago

One of Pfizer’s Duchenne gene therapy trials put on hold in wake of patient death as high-dose AAV concerns still cloud field

4 years ago

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