FDA says there will be no advisory committee review of Capricor Therapeutics BLA for Deramiocel, the companys lead cell therapy candidate for treating...
Nektar Therapeutics reports promising results from a mid-stage clinical trial of its experimental therapy rezpegaldesleukin for patients with moderate...
FDA tells healthcare providers to be aware of import alerts for specific Olympus medical devices that are being refused entry into the U.S. due to ong...
FDA says Usona Institute chief medical officer Michael C. Davis is returning to CDER as the Centers deputy director after being gone two and a half ye...
CDER acting director Jacqueline Corrigan-Curay decides to retire and will leave her post next month.
GE HealthCare recalls certain Carestation anesthesia devices due to the risk that they may not provide effective ventilation in certain situations.
New data from a Phase 2 study on Eli Lillys experimental bimagrumab showed that when combined with Novo Nordisk's Wegovy (semaglutide) it led to prese...
FDA posts an International Council for Harmonization draft guideline entitled Stability Testing of Drug Substances and Drug Products Q1.
