FDA releases the form FDA-483 with six observations from an inspection at the Samsung Biologics drug manufacturing facility in Incheon, Korea.
FDA grants Diakonos Oncology a fast-track designation for the companys dendritic cell vaccine, DOC1021, for use in patients with glioblastoma multifor...
PhRMA calls on the Supreme Court to hear a Danco Laboratories/FDA appeal of a 5th Circuit Court of Appeals decision restricting use of the abortifacie...
FDA denies without comment the specific requests in a UCB petition asking the agency to not approve an Apotex ANDA for generic Fintepla unless specifi...
Omeros stops the development of narsoplimab for treating immunoglobulin A nephropathy based on Phase 3 clinical trial data that did not show statistic...
AbbVie reports positive results from the head-to-head Phase 3 SEQUENCE study that evaluated the efficacy and safety of its Skyrizi (risankizumab) comp...
FDA publishes a final guidance entitled Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol.
FDA posts a draft guidance entitled Diabetic Foot Infections: Developing Drugs for Treatment.
