FDA identifies significant deficiencies at BayCare Integrated Service Center, an outsourcing facility in Temple Terrace, FL, following a March inspect...
FDA accepts for priority review a Jazz Pharmaceuticals supplemental BLA for Ziihera (zanidatamab-hrii) for use in combination regimens for first-line ...
A federal judge dismisses a lawsuit brought by homeopathy advocates and a product distributor challenging FDAs decision to tighten oversight of homeop...
Concerns that political pressure could undermine the U.S. drug approval system intensify this week after a new White House directive on psychedelic th...
FDA announces several actions aimed at accelerating the development of treatments for serious mental illness, following a recent executive order from ...
A recent FDA Warning Letter signals a broader regulatory focus on how drugmakers use artificial intelligence, according to a new analysis by law firm ...
FDA issues AbbVie a complete response letter for its BLA for trenibotulinumtoxinE, an investigational, fast-acting botulinum toxin intended for aesthe...
FDA sends an untitled letter to Incyte Corp., warning that portions of the companys consumer-facing Web site for Niktimvo (axatilimab-csfr) contain fa...
