Baxter recalls its Life200 Ventilator System due to the potential for battery failure involving its charging dongle.
FDA issues a one-item 483 after inspecting a Lonza Visp, Switzerland manufacturing facility.
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.
Former FDA commissioner Scott Gottlieb says Congress needs to design a framework for the modern, efficient regulation of medical artificial intelligen...
