Sanofi discontinues a Phase 2 study evaluating the safety and efficacy of oditrasertib (SAR443820/DNL788) on serum neurofilament light chain levels in...
FDA releases the form FDA-483 with 12 observations from a 2023 inspection at Chinas Nanchang Anobri drug manufacturing facility.
Zyno Medical recalls (Class 1 device correction) various models of its Z-800 Infusion System due to a defect in the air in-line software.
Federal Register notice: FDA announces that it approved a product submission that redeemed a priority review voucher Johnson & Johnsons supplemental ...
FDA releases the form FDA-483 with six observations from a 2023 inspection at the Republic of Koreas Aqualex cosmetic and drug manufacturing facility....
FDA accepts an Antag Therapeutics IND for its lead molecule, AT-7687, to begin a Phase 1 clinical trial to evaluate it for treating obesity.
CDRH posts a list of final and draft guidances it expects to publish in FY 2024.
While denying a Parenteral Technologies petition to force a change in pediatric acetaminophen directions for use, FDA says it is planning a safety ord...
