FDA approves a Bayer sNDA for its Mirena intrauterine system for extended use of up to eight years as a contraceptive.
FDA accepts for priority review an Astellas Pharma NDA for fezolinetant, a nonhormonal compound for treating moderate to severe vasomotor symptoms (ho...
FDA warns about the potential for needle stick injuries from recently recalled Haiou Needle Retractable Safety 1 mL syringe with 23G 1-inch needle and...
FDA is permitting Covid-19 vaccine makers to submit mouse data to expedite authorization of their omicron-protecting vaccine boosters, a move some see...
Federal Register final rule: FDA establishes a regulatory category for over-the-counter hearing aids and making related amendments to update the regul...
FDA says it has received 168 reports of deaths in more than 69,000 medical device reports associated with PE-PUR foam degradation in Philips Respironi...
FDA clears a Preceptis Medical 510(k) for expanded indications for its Hummingbird Tympanostomy Tube System for office-based pediatric ear tube proced...
FDA approves the first cell-based gene therapy for treating adult and pediatric patients with beta-thalassemia who require regular red blood cell tran...
