Federal Register notice: FDA makes available a final guidance entitled Assessing the Credibility of Computational Modeling and Simulation (CM&S) in Me...
FDA approves an AstraZeneca NDA for Truqap (capivasertib) for use with fulvestrant in certain adult patients with hormone receptor-positive, human epi...
FDA approves a Merck NDA for Keytruda (pembrolizumab) and its use with fluoropyrimidine- and platinum-containing chemotherapy for treating certain adu...
Asensus Surgical recalls its Senhance Surgical System due to malfunctions that cause unintended movement of the robotically assisted surgical device.
Braun Medical recalls its Infusomat Space Volumetric Infusion Pump System due to faulty occlusion alarms.
FDA approves Astellas Pharmas Xtandi (enzalutamide) for an expanded use treating non-metastatic castration-sensitive prostate cancer with biochemical...
Federal Register notice: FDA corrects a notice that appeared in the 7/8/2022 Federal Register that announced an agency determination of the regulatory...
Federal Register notice: FDA announces a 2/2/2024 advisory committee meeting to discuss pulse oximeter quality.
