Incyte's (INCY) skin cancer drug approval and Altimmune's obesity data are the key highlights from the biotech sector during the past week.
The FDA committee supports an accelerated approval of Biogen's (BIIB) tofersen for treating SOD1-ALS. The committee does not believe the data supports a traditional/standard approval for tofersen.
SOD1-ALS is a rare genetic form of the disease affecting approximately 330 people in the United StatesCAMBRIDGE, Mass., March 22, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced today the outcome of the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee meeting on tofersen, an investigational product for the treatment of superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). On the question, “Is the available evidenc