An FDA-funded survey of doctors who prescribe REMS-covered drugs finds that many doctors appreciate and use the REMS information and want more informa...
FDA clears an X-trodes 510(k) for its X-trodes Smart Skin device, a wireless wearable technology for advanced electrophysiological monitoring.
FDA grants Harmony Biosciences Holdings an orphan drug designation for pitolisant and its use in treating Prader-Willi syndrome.
FDA accepte for priority review a Merck supplemental BLA for Keytruda in combination with standard-of-care chemotherapy for treating patients with end...
ARS Pharmaceuticals says new study data will be submitted in the second quarter as part of a response to a 9/2023 FDA complete response letter on an N...
FDA warns Chinas Sichuan Deebio Pharmaceutical Co. about significant deviations in manufacturing active pharmaceutical ingredients.
A report of a patients liver failure leads to an FDA clinical hold against two RAPT Therapeutics Phase 2 trials involving zelnecirnon (RPT193).
PDC Pharma Strategy CEO Penelope Przekop says there are several reasons why the drug industry is not rapidly moving toward quality management programs...
