FDA warns Turkeys Pushclean Technology about CGMP violations in its manufacturing of over-the-counter drug products.
FDA warns South Koreas Aju Pharm about QS and MDR violations in its production of two Class 2 medical devices.
FDA says there will be no advisory committee review of Capricor Therapeutics BLA for Deramiocel, the companys lead cell therapy candidate for treating...
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.
A new study disputes previous assumptions about FDA inspections leading to more drug shortages at facilities receiving GMP citations.
