FDA warns San Diego, CA-based Samm Solutions about objectionable conditions in its role as the testing facility for two nonclinical laboratory studies...
FDA accepts for priority review an X4 Pharmaceuticals NDA for once-daily, oral mavorixafor to treat individuals aged 12 and older with WHIM (Warts, Hy...
FDA approves a Tenaya Therapeutics IND for the company to begin a Phase 1b trial of TN-401, an adeno-associated virus serotype 9-based investigational...
AdvaMed tells the National Cyber Director about domestic and international efforts involving FDA to harmonize medical device cybersecurity requirement...
Asensus Surgical recalls its Senhance Surgical System due to the potential for the devices to malfunction.
Federal Register notice: FDA determines that 17 listed drug products were not withdrawn from sale for safety or efficacy reasons.
FDA approves an Amgen BLA for Wezlana (ustekinumab-auub), an interchangeable biosimilar to Janssens Stelara for multiple inflammatory diseases.
FDA warns Denver, CO-based WAVi Co. about multiple violations in its manufacturing and distribution of the WAVi Desktop, an unapproved, adulterated, a...
