FDA+ channel feed – Endpoints News

FDA+ channel feed

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

Win or lose on the marketing OK, the FDA just gunned down GSK’s bright hopes for their BCMA therapy

5 years ago

Peter Marks on Covid-19 vaccine efficacy, EUAs and challenge trials

5 years ago

Concert gets BTD for alopecia drug, setting up a late-stage showdown with giant rival Pfizer

5 years ago

FDA bars the door — for now — against Merck’s star cancer drug after Roche beat them to the punch

5 years ago

Cellectis slammed after patient dies and FDA slaps a hold on their trial for an off-the-shelf CAR-T for multiple myeloma

5 years ago

FDA lifts partial hold on ADC, clearing way for a 2021 readout and two potential near-term approvals

5 years ago

Novartis loses biosimilar appeal as court upholds a 31-year monopoly by Amgen's Enbrel

5 years ago

FDA approvals roundup: Zogenix's Fintepla, Ultragenyx's Dojolvi, and Genentech's Phesgo

5 years ago

New standard of care? FDA hands Pfizer, Merck KGaA an OK for Bavencio in bladder cancer

5 years ago

On a roll, Merck blazes through a new segment of the biomarker trail

5 years ago

Heron earns a second slapdown from the FDA on pain med — shares wither

5 years ago

FDA rejects Intercept’s pitch for NASH as CEO fires back at the agency’s ‘evolving’ guidelines

5 years ago

Takeda takes a $200M hit after Novartis is forced to yank its marketing application for Xiidra

5 years ago

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