The U.S. Food and Drug Administration awarded Roche’s Alzheimer’s disease drug candidate Breakthrough Therapy Designation, bringing the IgG1 antibody gantenerumab closer to finally receiving full FDA approval.
AstraZeneca’s candidate breast cancer therapy Enhertu received a fourth Breakthrough Therapy Designation from the U.S. Food and Drug Administration after the health regulator issued another BTD based on a Phase III trial presented at the European Society for Medical Oncology Congress 2021.
Massachusetts-based biotechnology firm Biogen and its Tokyo-based partner Eisai are seeking a speedy approval from the U.S. Food and Drug Administration for a second Alzheimer’s disease drug, lecanemab.
The U.S. Food and Drug Administration greenlit the classification of California-based biotechnology firm Genentech’s Venclexta (venetoclax) and azicitidine combination as a Breakthrough Therapy Drug.
Data from a mid-stage clinical study of an experimental vaccine candidate developed by Affinivax and Astellas Pharma for Streptococcus pneumoniae shows ASP3772 is well tolerated and generated an antibody response against the deadly bacterial infection.
The U.S. Food and Drug Administration made the decision to grant Breakthrough Therapy Designation to Mirati Therapeutics’ adagrasib for the potential treatment of non-small cell lung cancer (NSCLC) in patients harboring the KRASG12C mutation after systemic therapy.
Novartis announced new Phase II data for iptacopan (LNP023), an investigational oral treatment for paroxysmal nocturnal hemoglobinuria (PNH), presented at the 26th Annual Congress of the European Hematology Association (EHA).
One month after acquiring Five Prime Therapeutics and the company’s Phase III ready anti-FGFR2b antibody bemarituzumab for $1.9 billion, Amgen announced that the U.S. Food and Drug Administration awarded Breakthrough Therapy Designation to the asset as a first-line treatment for certain types of gastric cancer.
The U.S. Food and Drug Administration granted vTv Therapeutics’ TTP399 Breakthrough Therapy designation for type 1 diabetes.
Gilead Company Kite submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration for Tecartus (brexucabtagene autoleucel) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.