FDA approves an Alucent Medical Phase 1 clinical trial of Natural Vascular Scaffolding, a novel combination drug/device therapy for treating periphera...
Ionis Pharmaceuticals says that primary endpoints were met in its Phase 3 NEURO-TTR study of Ionis-TTR (inotersen) in patients with familial amyloid p...
Federal Register notice: FDA requests comments related to the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program.
FDA grants Imara a rare pediatric disease designation for IMR-687, the companys lead product candidate for treating sickle cell disease.
FDA accepts for review an Aerie Pharmaceuticals NDA for Rhopressa (netarsudil ophthalmic solution) 0.02%, indicated for treating elevated intraocular ...
CDER officials say expanded access decisions have not led to a negative regulatory decision regarding a drug application.
FDA issues a Form 483 to Badrivishal Chemicals & Pharmaceuticals (Maharashtra, India) related to a 8/2016 facility inspection that cited significant G...
Federal Register notice: FDA announces the availability of a guidance for industry on Three-Month Extension of Certain Tobacco Product Compliance Dead...