Author Archives: Jose Marques Lopes PhD

FDA Publishes Guidance to Help in Developing New ALS Therapies

After gathering input from patients, researchers, and advocates, the U.S Food and Drug Administration (FDA) has released new guidance on the development of therapies for amyotrophic lateral sclerosis (ALS). Among its recommendations, it is advising more communication with companies early on in the product development process, access to…

Daiichi Sankyo Seeks Approval to Market Radicava in Brazil

Daiichi Sankyo is looking to market the amyotrophic lateral sclerosis (ALS) treatment Radicava (edaravone) in Brazil after reaching a licensing agreement with the therapy’s maker, Mitsubishi Tanabe Pharma. The company will submit a regulatory application through its local subsidiary, and expects to commercialize Radicava in…