Federal Register notice: FDA seeks comments on an information collection revision entitled Investigational New Drug Applications 21 CFR Part 312.
FDA has approved Takedas Livtencity as the first approved treatment for adults and pediatric patients with post-transplant cytomegalovirus infection t...
FDA approves an Aadi Bioscience NDA for Fyarro (sirolimus protein-bound particles for injectable suspension) for treating adult patients with locally ...
Pfizer asks a California federal court for an injunction against an ex-employee it says took confidential information and trade secrets.
FDA places a partial clinical hold a Kura Oncology Phase 1b study (KOMET-001) of KO-539 in patients with relapsed or refractory acute myeloid leukemia...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Immunomedics breast cancer therapy Trodelvy.
FDA warns Minneapolis-based Smiths Medical about Medical Device Reporting and Quality System violations in its work as a specification developer and m...
FDA schedules a 12/14 Webinar on the medical device de novo classification process and its guidance document updates.