The U.S. Food and Drug Administration granted Breakthrough Therapy designation to Austin, Texas-based Savara Inc.’s Molgradex for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP).
Usona Institute received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for psilocybin in the treatment of major depressive disorder (MDD).
Novartis secured U.S. FDA Breakthrough Therapy Designation for the investigational medicine capmatinib, which the company aims to file for approval during 2019 against a mutated form of lung cancer.
AstraZeneca’s BTK inhibitor Calquence won Breakthrough Therapy Designation from the U.S. FDA as a monotherapy treatment for patients with chronic lymphocytic leukemia (CLL).
The U.S. Food and Drug Administration approved Pfizer Inc.’s oral drug tafamidis to treat a rare and fatal heart disease called transthyretin amyloid cardiomyopathy.
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.