FDA lifts a clinical hold on Biomea Fusions Phase 1-2 clinical trials of its investigational covalent menin inhibitor BMF-219 in Type 2 and Type 1 dia...
Investigative journalists write in BMJ about FDA advisory committee members financial conflicts of interest in the consideration of Lillys Kisunla whi...
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...
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...
