Coya aligns with FDA on plans for developing COYA 302 for ALS

After two meetings with the U.S. Food and Drug Administration (FDA), Coya Therapeutics says it’s received constructive feedback — and has reached an alignment with the agency regarding development plans for COYA 302, its therapy candidate for people with amyotrophic lateral sclerosis (ALS). The company held the two…

FDA approves tofersen, now Qalsody, as treatment for SOD1-ALS

The U.S. Food and Drug Administration (FDA) has granted conditional approval to Biogen’s tofersen, now named Qalsody, for the treatment of amyotrophic lateral sclerosis (ALS) associated with mutations in the SOD1 gene. The decision, which marks the first conditional approval for ALS in the country, comes about eight…

BrainStorm Plans to File for NurOwn Approval in US for ALS

Brainstorm Cell Therapeutics is preparing to file an application with the U.S. Food and Drug Administration (FDA) requesting approval of its cell-based therapy NurOwn for amyotrophic lateral sclerosis (ALS). The decision to submit a biologics license application was based on “the totality of the evidence from NurOwn’s clinical…

FDA Shares Plan for ALS, Other Neurodegenerative Diseases

The U.S. Food and Drug Administration (FDA) has published on its website a five-year action plan meant to help advance the development of — and access to — treatments that may make life better and longer for people with amyotrophic lateral sclerosis (ALS) or other rare neurodegenerative diseases. The…