News

US FDA eliminates risk evaluation, mitigation strategies for CAR-T cancer therapies
The U.S. Food and Drug Administration said on Friday it had eliminated risk evaluation and mitigation strategies (REMS), a ...
BioPharma Dive9h
FDA takes major step to ease access to CAR-T therapy
The agency removed some onerous requirements for the complex cancer drugs and reduced restrictions on patients’ ...
MPR10h
FDA Removes REMS, Reduces Monitoring Requirements For Breyanzi and Abecma
The Breyanzi REMS program and the Abecma REMS program were established due to the risk of cytokine release syndrome and neurologic toxicities.
Bristol Myers, Gilead, J&J, Novartis win favorable FDA label updates for cell therapies
Bristol Myers (BMY) receives FDA approval for label updates for Breyanzi and Abecma, that can ease access to the cancer cell ...
FDA to offer faster drug reviews to companies promoting 'national priorities'
The Food and Drug Administration says it will begin offering faster reviews to new medicines that align with Trump ...
Ultragenyx Gets FDA Designation to Expedite GTX-102 Drug Development
Ultragenyx Pharmaceutical received breakthrough therapy designation from the U.S. Food and Drug Administration for its drug GTX-102, which is designed to treat people with Angelman syndrome. Angelman ...
Food Safety News21h
FDA steps up enforcement on imports including soft cheese and seafood
The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries.
STAT4d
Top drug regulator is retiring as FDA departures mount
WASHINGTON — Jacqueline Corrigan-Curay, the top drug regulator at the Food and Drug Administration, is retiring from the ...