Jun 17, 2021 | News, Regulatory
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Novartis’ prostate cancer drug therapy that is currently in Phase III development. The experimental treatment, called Lu-PSMA-617, has illustrated substantial...
Apr 20, 2021 | News, Regulatory
The U.S. Food and Drug Administration (FDA) awarded Amgen’s cancer antibody drug, bemarituzumab, Breakthrough Therapy Designation for a first-line treatment for specific kinds of gastric cancer. The decision comes after the FDA reviewed data from Phase II FIGHT...
