FDA grants a fast track designation to Scancells advanced melanoma investigational drug iSCB1+.
FDA commissioner Marty Makary says the agency is still weighing candidates to lead CBER as controversial director Vinay Prasad prepares to leave the a...
Rocket Pharmaceuticals sells an FDA rare pediatric disease priority review voucher for $180 million to support its gene therapy pipeline.
Intellia Therapeutics starts a rolling BLA submission for its experimental gene-editing therapy lonvoguran ziclumeran, or lonvo-z, as a one-time treat...
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...
