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...
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...
Medline Industries recalls certain lots of its medical procedure kits that include recalled Medtronic Aortic Root Cannulas due to a potential safety r...
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.
