VBL Therapeutics announced that an investigational new drug (IND) application has received clearance from the U.S. FDA for approval to commence a phase 2 trial in patients with recurrent glioblastoma multiforme (rGBM). The IND was submitted by Patrick Wen, M.D.,...
Bionomics announced the U.S. FDA has granted Fast Track designation to the BNC210 development program for the treatment of Post-Traumatic Stress Disorder (PTSD) and other trauma-related and stressor-related disorders. Bionomics is currently developing a...
Compugen announced the U.S. FDA has cleared its investigational new drug (IND) application for COM902, its immuno-oncology therapeutic antibody targeting TIGIT in patients with advanced malignancies. Under this IND, the Company intends to initiate a Phase...
Mirum Pharmaceuticals announced the U.S. FDA has granted Breakthrough Therapy Designation for maralixibat for the treatment of pruritus associated with Alagille syndrome (ALGS) in patients 1 year of age and older. The Breakthrough Therapy Designation of...
Biogen and Alkermes have received approval from the U.S. FDA for Vumerity (diroximel fumarate), a novel oral fumarate with a distinct chemical structure, for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome,...
Autolus Therapeutics reported the U.S. FDA has granted orphan drug designation to AUTO1, a CD19 CAR T cell investigational therapy, for treatment of acute lymphoblastic leukemia (ALL) patients. Orphan drug designation is granted by the FDA Office of Orphan Products...
