Elon Musks Neuralink says FDA has approved a human trial for its brain implant technology to be used to control external technology.
FDA approves a Lexicon Pharmaceuticals NDA for Inpefa (sotagliflozin), a once-daily oral tablet to reduce the risk of cardiovascular death, hospitaliz...
Federal Register notice: FDA determines that Purdue Pharmas Chirocaine (levobupivacaine) injection was not withdrawn due to safety or effectiveness re...
Mirati Therapeutics says its sitravatinib failed to meet the primary endpoint in the Phase 3 SAPPHIRE lung cancer study.
FDA publishes a guidance with recommendations to help manufacturers comply with the special controls related to non-clinical performance data for gyne...
FDA publishes a guidance with its recommendations on adjusting for covariates in the statistical analysis of randomized clinical trials in drug develo...
The latest Sedgwick recall index report details increases in drug and medical device recalls in the first quarter of 2023 over the fourth quarter of 2...
FDA grants Human Immunology Biosciences an orphan drug designation for felzartamab, an investigational agent for treating primary membranous nephropat...
