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FDA approves Biogen's drug for rare form of ALS.

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Source: The New York Times
FDA approves Biogen's drug for rare form of ALS.
Photo: The New York Times
TL;DR Summary

The FDA has approved Biogen's drug, Qalsody, for a rare genetic form of ALS that targets a mutation in the SOD1 gene. The drug will be priced "within a range comparable to other recently launched ALS treatments." Qalsody is the first conditional approval granted for a medication for ALS, despite uncertainty about its effectiveness. Biogen will be required to provide confirmatory evidence from ongoing clinical research to keep the drug on the market. Before Qalsody, only three ALS medications were approved in the United States, and they have not significantly altered the course of the disease.

Topics:business#als#biogen#fda#genetic-mutation#health#qalsody
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  1. F.D.A. Approves Drug for Rare Form of A.L.S.  The New York Times
  2. FDA grants accelerated approval for Biogen ALS drug that treats rare form of the disease  CNBC
  3. Drug for rare form of Lou Gehrig's disease OK'd by FDA  The Associated Press
  4. Moment of Truth for Biogen and Ionis’s SOD1-ALS Drug  BioSpace
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