FDA accepts a Merck BLA for a subcutaneous formulation of Keytruda (pembrolizumab) for its use across all previously approved solid tumor indications....
FDA approves Fresenius Kabi BLAs for biosimilar denosumab products that reference Amgens Prolia and Xgeva.
FDA clears a Vasorum 510(k) for the Celt ACD Plus vascular closure device.
A Senate floor vote moves Marty Makary one step closer to becoming the next FDA commissioner.
FDA warns Chinas Yangzhou Sion Commodity Co. about CGMP violations in its manufacturing of finished drugs.
AstraZeneca says new study data on Tagrisso (osimertinib) show an improved overall survival trend in certain patients with non-small cell lung cancer....
FDA warns Denver, CO-based Exer Labs about illegally marketing its Exer Scan device that has Quality System Regulation violations.
FDA says it received 803 medical device reports on Bayers withdrawn Essure birth control implant in 2024, the lowest number since the device was pulle...
