FDA warns Unetixs Vascular about Quality System violations in its manufacturing of vascular diagnostic ultrasound systems.
FDA warns KVK-Tech about CGMP violations in its production of finished drugs.
FDA announces three steps intended to make use of laparoscopic power morcellators in gynecologic surgeries.
FDA accepts for review a Genentech BLA for a fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase, administer...
FDA approves a Perrigo Pharmaceutical ANDA for the first generic of Tevas ProAir HFA (albuterol sulfate) inhalation aerosol for treating or preventing...
FDA releases its latest batch of Warning Letters that includes Biomedix, JHS Svendgaard Hygiene Products, KVK-Tech, Unetixs Vascular and Yibin Lihao B...
FDA clears an Emagine Solutions Technology 510(k) for its cell phone VistaScan mobile ultrasound.
FDA clears a new version of the LivaNova heater-cooler system 3T to help reduce the risk of patient infections.