CDER researchers describe efforts to develop immunomodulatory therapies for Covid-19.
FDA issues a guidance to help sponsors develop drugs to treat breast cancer in males.
Federal Register notice: FDA seeks comments on an information collection entitled Medical Devices; Humanitarian Use Devices (HUD) 21 CFR Part 814.
Federal Register notice: FDA seeks comments on an information collection extension for electronic records and signatures.
FDA commissioner Stephen Hahn tries to reassure healthcare professionals that the agency is sticking to science and not cutting corners in its decisio...
FDA approves a Lantheus and Progenics Pharmaceuticals supplemental NDA for Vialmix RFID for Definity.
An FDA drug safety alert warns about reports of toxic anterior segment syndrome following intraocular administration of compounded drugs using moxiflo...
FDA clears a MagVenture 510(k) for its TMS Therapy as an adjunct treatment for obsessive-compulsive disorder.