Bayer submits a supplemental NDA for oral androgen receptor inhibitor Nubeqa (darolutamide), seeking approval for its use in combination with androgen...
The FDA Oncology Drugs Advisory Committee votes not to recommend using immune checkpoint inhibitors in first-line advanced gastric cancer with PD-L1 e...
AbbVie says a pivotal Phase 3 (TEMPO-1) trial for tavapadon in early Parkinsons disease met its primary and secondary endpoints.
Federal Register notice: FDA proposes to reclassify qualitative hepatitis B virus (HBV) antigen assays, qualitative and quantitative HBV antibody assa...
Federal Register notice: FDA sends to OMB an information collection extension entitled Medical Device Recall Authority.
Merck says a trial assessing favezelimab and Keytruda (pembrolizumab) failed to meet its primary endpoint in patients with previously treated PD-L1 po...
FDA posts forms FDA-483 issued following inspections at Samsung Bioepis in Incheon, Republic of Korea, and Terumo Yamaguchi in Yamaguchi, Japan.
Two House Democrat lawmakers ask the HHS Office of Inspector General to investigate potential conflict-of-interest appearances raised in last months N...
