Genfit’s elafibranor was granted Breakthrough Therapy Designation by the U.S. FDA for the treatment of Primary Biliary Cholangitis (PBC) in adults with inadequate response to ursodeoxycholic acid.
Johnson & Johnson’s drug Balversa won U.S. approval as the first targeted therapy for advanced bladder cancer, the Food and Drug Administration announced.
PhaseBio Pharmaceuticals’ antiplatelet drug PB2452 received Breakthrough Therapy designation from the U.S. FDA.
The return on R&D investment for leading biopharmaceutical manufacturers fell to a nine-year low while the U.S. FDA approved a record-breaking amount of novel medicines during 2018.
Novartis announced that the U.S. Food and Drug Administration granted crizanlizumab (SEG101) Breakthrough Therapy designation for the prevention of vaso-occlusive crises in patients of all genotypes with sickle cell disease.
Concentric Analgesics Inc. announced today that the clinical-stage biopharmaceutical company received Breakthrough Therapy designation from the U.S. Food and Drug Administration for CA-008 in post-surgical pain.
Amgen and AstraZeneca announced that the U.S. FDA granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma without an eosinophilic phenotype.
Genentech announced that the U.S. Food and Drug Administration granted Breakthrough Therapy Designation for Xolair (omalizumab) for the prevention of severe allergic reactions following accidental exposure to one or more foods in people with allergies.
The FDA approved Azedra injection for intravenous use for treating patients age 12 and older with rare tumors of the adrenal gland that cannot be surgically removed, have spread beyond the original tumor site and require systemic anticancer therapy.
Concerted effort by governments, regulators, and industry is rapidly expanding development of new therapies for the more than 7,000 known rare diseases.
