Two leading House Republicans ask FDA for information on the pressure they say may have come from the White House to approve Covid vaccine booster sho...
FDA acting commissioner Janet Woodcock asks the U.S. Patent and Trademark Office to open a dialog on how the two agencies can work together to promote...
Jacobus Pharmaceutical recalls three lots of Ruzurgi (amifampridine) 10 mg tablets due to potential contamination with yeast, mold, and aerobic bacter...
FDA clears an inTravent Medical Partners 510(k) for the SoloPass system for aiding in the frontal placement of intra-ventricular catheters.
FDA accepts for review an Axsome Therapeutics NDA for AXS-07 (meloxicam-rizatriptan) for treating migraine headaches.
FDA grants Nyxoah a breakthrough device designation for its Genio bilateral hypoglossal nerve stimulation system and its use in treating patients with...
FDA clears Anika Therapeutics Tactoset for an expanded indication.
FDA removes a clinical hold against KalVista Pharmaceuticals and its Phase 2 clinical trial of KVD824 for oral prophylactic treatment of hereditary an...