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New treatment methods are expected to be created for ALS patients. Amylyx submitted NDA of AMX0035 in the United States PharmaSources/Yi
December 02, 2021
On November 2, Amylyx Pharmaceuticals announced that it had submitted a new drug application of AMX0035 for the treatment of amyotrophic lateral sclerosis (ALS) to FDA.
Amylyx Pharma plans to file ALS therapy with the EMA this year pharmatimes
April 16, 2021
Amylyx Pharmaceuticals has announced its intention to submit a marketing authorisation application for its investigational amyotrophic lateral sclerosis (ALS) therapy AMX0035 to the European Medicines Agency (EMA) by the end of 2021.
Amylyx announces FDA granted orphan drug designation for AMX0035 to treat Wolfram syndrome pharmaceutical-business-review
November 19, 2020
Amylyx Pharmaceuticals announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to AMX0035 for the treatment of Wolfram syndrome.
Amylyx Pharmaceuticals Announces New England Journal of Medicine Publication of Pivotal AMX0035 Data Demonstrating Statistically Significant Benefit in People with ALS drugs.com
September 24, 2020
Amylyx Pharmaceuticals, Inc. today announced the publication of results from the pivotal CENTAUR trial evaluating AMX0035.
Amylyx Pharmaceuticals announces AMX0035 demonstrated statistically significant treatment benefit in ALS in CENTAUR trial pharmaceutical-business-review
December 20, 2019
Amylyx Pharmaceuticals, Inc., a pharmaceutical company focused on developing new treatments for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases ...