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.
Tytek Medical recalls its PneumoDart-Pneumothorax Needle due to the risk of blocked needles caused by an adhesive left over from assembly.
FDA issues two final guidances to help device makers that seek Clinical Laboratory Improvement Amendments waivers for certain products.