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...
Citing payor management concerns, Indivior says it is discontinuing sales and marketing for schizophrenia drug Perseris (risperidone).
Bausch+Lombs Synergetics unit recalls its I-PACK Injection Kit with Drape, which is used for the administration of an intravitreal (back of the eye) i...
FDA publishes draft guidances with recommendations on 510(k) submissions for dental composite resins and curing lights.
