FDA clears a Lensar 510(k) for its IntelliAxis-L, the companys latest astigmatism management feature to guide toric intraocular lens alignment in cata...
FDA clears a Neusoft Medical Systems 510(k) for its new 128-slice NeuViz Prime CT scanner.
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.