Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Jazz Pharmaceuticals Sunosi (solriamfetol Hcl)....
Federal Register notice: FDA seeks comments on an information collection extension entitled Generic Drug User Fee Program.
Heron submits an NDA for its HTX-019 injectable emulsion to prevent postoperative nausea and vomiting in adults.
FDA clears a Lunit 510(k) for its Insight MMG, an artificial intelligence application for breast cancer detection.
FDA says it is working with Medtronic to evaluate outcomes after cardiac perforation following implantation of leadless pacemaker systems.
FDA approves a new renal cell carcinoma indication for Mercks Keytruda.
FDA says its Division of Drug Information pharmacists are available to answer consumer questions about taking drugs.
FDA updates possible mitigation strategies to reduce the risk of nitrosamine drug substance-related impurities in drug products.