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.
FDA issues one final and one draft guidance related to Section 506J notifications of medical device shortages.
FDA publishes 22 new and 18 revised product-specific guidances for developing generic drugs.
