FDA grants fast track designation to TransThera Sciences experimental Phase 2 cholangiocarcinoma drug.
An FDA inspection leads to a 10-item Form FDA-483 issued to Innoveix Pharmaceuticals that took issue with the firms GMPs for sterile drug products.
FDA approves an ANI Pharmaceuticals supplemental NDA for purified cortrophin gel (repository corticotropin) for treating certain chronic autoimmune di...
FDA extends to 2/28/22 the PDUFA action date for a Janssen BLA for its cilta-cel multiple myeloma treatment.
FDA warns CellEra about multiple repeat Quality System violations in its as a specification developer and distributor of sterile wound dressings.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Sarepta Therapeutics Vyondys 53 (golodirsen).
Federal Register notice: FDA determines for patent restoration purposes the regulatory review period for Biogens Spinraza (nusinersen sodium).
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Daiichi Sankyos Enhertu.