Bristol-Myers Squibb reports disappointing topline results from its Phase 3 CheckMate-331 study evaluating Opdivo (nivolumab) versus the current stand...
FDA clears a FibriCheck 510(k) for its smartphone application that monitors heart rhythm disorders by using an optical signal originating from a smart...
FDA grants Sutro Biopharma an orphan drug designation for STRO-001 for treating multiple myeloma.
FDAs Anesthetic and Analgesic Drug Products Advisory Committee votes 8 to 7 to recommend not approving Trevenas next-generation opioid oliceridine inj...
Cardiologist Rita Redberg says in a Health Affairs online post that FDA should require high-quality evidence for approval of medical devices.
The CDER Office of Generic Drugs sets a new record for generic drug approvals.
FDA clears a TransEnterix 510(k) clearance for 3 millimeter diameter instruments for its Senhance System for use in microlaparoscopic surgeries.
FDA approves a Boehringer Ingelheim supplemental NDA for new labeling on its Stiolto Respimat (tiotropium bromide and olodaterol) that includes data s...