Federal Register notice: FDA withdraws approval of a Takeda NDA for Exkivity (mobocertinib succinate) capsules after a confirmatory study failed to de...
FDA grants Bayer-owned Asklepios BioPharmaceutical a fast track designation for AB-1005, a gene therapy candidate for treating moderate Parkinsons dis...
Federal Register notice: FDA releases two draft guidances entitled Dental Composite Resin Devices Premarket Notification (510(k)) Submissions and Den...
FDA clears an Oticon Medical 510(k) for its active transcutaneous bone conduction hearing system, the Sentio System.
AbbVie submits a supplemental NDA for Rinvoq and its use in treating adult patients with giant cell arteritis.
FDA publishes draft guidances with recommendations on 510(k) submissions for dental composite resins and curing lights.
Hamilton Medical recalls its software for the Hamilton-C6 Medical Ventilator because the ventilator may fail to restart ventilation if it enters senso...
FDA says Baxter is recalling its Life2000 ventilators that were distributed in the U.S. between 8/2023 and 4/2024 due to potential battery charger don...
