FDA approves a Heron Therapeutics NDA for Cinvanti (aprepitant) injectable emulsion, a P/neurokinin-1 receptor antagonist indicated in adults, in comb...
As part of an adverse event harmonization effort, FDA says it is no longer adding new adverse event codes for Medical Device Reporting in response to ...
FDA has approved a Teligent ANDA for a generic copy of Promius Pharmas Sernivo, indicated for treating mild-to-moderate plaque psoriasis.
FDA issues a combined Warning Letter to India-based Lupin after two drug manufacturing facilities at Goa and Indore were inspected earlier this year a...
Federal Register notice: FDA seeks comments on an information collection for Class II Special Controls Guidance Document: Labeling for Natural Rubber ...
Federal Register notice: FDA announces an 11/30 to 12/1 Blood Products Advisory Committee advisory committee meeting.
Insys Therapeutics asks FDA not to approve any ANDA for generic Syndros based on an agency waiver of bioequivalence testing.
FDA publishes a guidance to help drug sponsors evaluate the effects of psychoactive drugs on the ability to operate a motor vehicle.