Tag Archive for: accelerated approval program

The U.S. Food and Drug Administration has extended the review of Biogen Inc.’s (BIIB.O) experimental treatment for an inherited form of amyotrophic lateral sclerosis (ALS) by three months, the company said on Monday.

The federal agency granted accelerated approval for Tafinlar (dabrafenib) + Mekinist (trametinib) for the treatment of adult and pediatric patients 6 years of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no other treatment options.