FDA approves Gileads Yeztugo as the only HIV pre-exposure prophylaxis twice-yearly option.
FDA publishes a guidance on its implementation of the post-Warning Letter meeting established in the GDUFA 3 commitment letter to allow eligible facil...
House Energy and Commerce Committee ranking Democrat Frank Pallone calls for a bipartisan committee investigation of HHS secretary Robert Kennedys act...
CBER director Vinay Prasad has been appointed as FDAs chief medical and scientific officer, a new combination role for commissioner Marty Makary.
FDA warns Irving, TX-based Reset Technology Corp. about Quality System and other violations in its production of two dental devices.
Sarepta Therapeutics halts shipments of its gene therapy Elevidys (delandistrogene moxeparvovec‑rokl) to non‑ambulatory Duchen...
FDA warns Indias Kenil Private Healthcare about CGMP violations in its production of finished drugs.
FDA approves updated labeling on Pfizers s Talzenna (talazoparib) in combination with Xtandi (enzalutamide) for men with metastatic castration-resista...
