FDA clarifies its policies for compounders of GLP-1 products for weight-loss and treating diabetes following a court ruling in Texas that denied a pre...
Dexcom says it received an FDA Warning Letter following inspections at the companys facilities in San Diego, CA and Mesa, AZ.
HHS offers its 80,000 federal employees, including FDA, up to a $25,000 buyout to retire or leave their government employment as part of new move to c...
FDA belatedly inspects Indias Glenmark Pharmaceuticals after a recent ProPublica investigative report found that the agency hadnt shifted any attentio...
Fresenius Kabi recalls its Ivenix LVP software that is embedded in its Ivenix Infusion System due to reports about certain anomalies associated with t...
FDA grants Plus Therapeutics an orphan drug designation for Rhenium (186Re) Obisbemeda, a radiotherapy for treating leptomeningeal metastases in patie...
FDA clears a Zimmer Biomet 510(k) for its Persona Revision SoluTion Femur, a revision knee implant for patients who have sensitivities to certain meta...
Federal Register notice: FDA makes available its decision to deny a request for a hearing on a CDER recent refusal to approve a Vanda supplemental NDA...