FDA+ channel feed – Endpoints News

FDA+ channel feed

FDA touts advanced manufacturing to address Covid-19 shortfalls

5 years ago

Long journey for DBV peanut patch ends in rejection by FDA

5 years ago

J&J gets a fresh OK for esketamine, but is it really the game-changer for depression Trump keeps tweeting about?

5 years ago

FDA hands MorphoSys and Incyte a quick OK on their potential blockbuster CAR-T alternative

5 years ago

Roche snags an FDA approval for an advanced melanoma drug cocktail — but it's up against some fierce competition

5 years ago

Glycolic acid, TCA among FDA's proposed additions to 503B bulk drugs list

5 years ago

House approves $3.2 billion FDA budget

5 years ago

FDA keeps Solid Bio's troubled Duchenne MD gene therapy on clinical lockdown in latest setback

5 years ago

Gilead’s Kite snares a landmark FDA OK on a $373,000 CAR-T therapy — which comes with bragging rights to the first true franchise op

5 years ago

Sobi's high-priority rare disease drug runs into a wall at EMA

5 years ago

AstraZeneca COPD drug finally gets OK from FDA, inching closer to GSK leader

5 years ago

PDUFA VII: FDA, industry preview their reauthorization wish lists

5 years ago

FDA lifts hold on CymaBay’s NASH drug, but the company may still leave the ailing field

5 years ago

Jazz Pharmaceuticals gets FDA OK for cataplexy drug as it prepares to replace old cash cow

5 years ago

FDA kicks off GDUFA III reauthorization process

5 years ago

Acadia’s shot at beating a ‘fickle’ major depression challenge misses the mark in a failed PhIII

5 years ago

House committee advances bills aimed at orphan exclusivity, generic labeling and continuous manufacturing

5 years ago

The $1B Merck-Bayer drug that divided cardiologists in March gets priority review

5 years ago

Despite safety, efficacy concerns, FDA AdCom narrowly recommends Mallinckrodt drug

5 years ago

FDA raises questions about Mallinckrodt's HRS-1 drug before advisory hearing

5 years ago

Experts urge transparency, advisory committee review for Covid-19 vaccines

5 years ago

FDA AdCom recommends GSK’s anti-BCMA drug for approval 12-0 despite searing in-house review — does it matter?

5 years ago

FDA rejects Verrica’s skin warts pitch, a month after flagging application ‘deficiencies’

5 years ago

CytoDyn shares slammed as BLA filing for leronlimab in HIV hits a wall

5 years ago

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