FDA+ channel feed – Endpoints News

FDA+ channel feed

Overworked and ready for expansion: FDA's cell and gene therapy office preps to add about 100 new positions

3 years ago

FDA's top generic drug leader puts in her two weeks as GDUFA III looms

3 years ago

Another Cipla site lands a Form 483 over cleaning issues and QC controls

3 years ago

FDA adcomm takes down Secura Bio's leukemia drug after final trial results show potential OS detriment

3 years ago

FDA's outside experts vote in favor of Ferring's fecal transplant for C. difficile, setting the stage for Seres

3 years ago

ODAC gives a big thumbs-down to Oncopeptides' dangling accelerated approval in multiple myeloma

3 years ago

Knives out at ODAC with vote against accelerated approval for Spectrum lung cancer drug

3 years ago

'Practically clean' FDA user fees reauth will be included in spending bill wrapping up next week

3 years ago

FDA's OCE makes the case for accelerated approval rider in user fee reauthorization

3 years ago

Updated: Eli Lilly's RET drug notches tumor-agnostic accelerated approval, full FDA OK in NSCLC

3 years ago

Catalent’s Covid-19 vaccine manufacturing site hit with Form 483 over foreign objects in vials and other QC issues

3 years ago

Some Medtronic insulin pumps are vulnerable to hackers, FDA warns

3 years ago

Updated: A week after GSK pulls one Zejula indication, FDA sets ODAC meeting to review revising label further

3 years ago

San Diego antifungal player nabs priority review for bloodstream infection treatment

3 years ago

Two CRLs later, FDA endorses drug to prevent hearing loss associated with chemo

3 years ago

Rising overdose deaths: Ohio State experts to review FDA's opioids plan and provide 'actionable recommendations'

3 years ago

EMA takes a stand against interchangeability, says all approved biosimilars are interchangeable

3 years ago

FDA slams Spectrum and Oncopeptides cancer drugs over efficacy concerns ahead of ODAC meeting

3 years ago

Heron secures FDA approval after R&D head count chop

3 years ago

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

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