FDA accepts for review a Fortress Biotech NDA for CUTX-101 (copper histidinate) for treating Menkes disease.
Tenpoint Therapeutics reports positive topline results from BRIO-II, the companys second Phase 3 pivotal trial evaluating Brimochol PF (brimonidine) f...
FDA clears a CapsoVision 510(k) for its CapsoCam Plus capsule endoscopy system for remote ingestion.
Pfizer reports positive topline results from its pivotal Phase 3 CREST trial evaluating sasanlimab for combination use with Bacillus Calmette-Gurin in...
Federal Register notice: FDA announces that a priority review voucher was used with the agencys 12/20/2024 approval of Vertex Pharmaceuticals Alyftrek...
FDA says it will review an Agios sNDA for a new Pyrukynd indication and sets a 9/7 PDUFA action date.
FDA grants fast track designation to Marengos invikafusp T cell activator for some colorectal cancers.
FDA clears a ZuriMED Technologies 510(k) for the FiberLocker System for rotator cuff repair reinforcement.
