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, CDC, and NIH announce an 11/25 public workshop entitled Live Biotherapeutic Products to Prevent Necrotizing Enterocoliti...
Two drug trade associations support an FDA approach to postapproval manufacturing changes in biosimilar and interchangeable biosimilar products.
FDA approves AstraZenecas Tagrisso for some non-small cell lung cancers.
Federal Register notice: FDA sends to OMB an information collection extension entitled Medical Device Recall Authority.
