FDA lifts a clinical hold against Mersana Therapeutics Phase 1 clinical trial of XMT-2056, a systemically administered Immunosynthen STING-agonist ant...
FDA grants Sage Therapeutics an orphan drug designation for SAGE-718 and its use in treating Huntingtons disease.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Fresenius Kabis Omegaven (fish oil triglyceride...
Three trade groups raise concerns and make suggestions for the FDA Information Technology Strategy.
FDA warns Omaha, NE-based Ali Pharmaceutical Manufacturing about significant CGMP deviations for active pharmaceutical ingredients.
FDA warns San Diego, CA-based Samm Solutions about objectionable conditions in its role as the testing facility for two nonclinical laboratory studies...
FDA accepts for priority review an X4 Pharmaceuticals NDA for once-daily, oral mavorixafor to treat individuals aged 12 and older with WHIM (Warts, Hy...
FDA approves a Tenaya Therapeutics IND for the company to begin a Phase 1b trial of TN-401, an adeno-associated virus serotype 9-based investigational...
