FDA Gives Accelerated Approval to Biogen’s ALS Drug

Published on April 25, 2023

Imagine you’re a plant trying to grow, but you need extra sunlight to thrive. Well, that’s how Biogen’s drug for treating amyotrophic lateral sclerosis (ALS) feels under the U.S. Food and Drug Administration’s accelerated approval pathway! The FDA has given the green light to Qalsody, a drug specifically designed to treat an inherited form of ALS. Just like sunlight gives energy to plants, this medication aims to provide hope and relief for those affected by an aggressive neurodegenerative disease. The accelerated approval process allows certain drugs to be approved based on promising preliminary data, recognizing the urgent need for effective treatments. With this monumental regulatory decision, patients with inheritable ALS can now have access to Qalsody sooner, potentially slowing down the progression of their condition. This FDA approval highlights the importance of ongoing research and innovation in finding solutions for rare diseases. To learn more about Biogen’s breakthrough drug and its impact on ALS treatment, check out the full article!

The U.S. Food and Drug Administration has approved Biogen Inc’s drug for treating an inherited form of amyotrophic lateral sclerosis (ALS), the health regulator said on Tuesday. The drug, branded as Qalsody, got a green light under the agency’s accelerated approval pathway…

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