FDA Grants Orphan Drug Designation to Pridopidine

FDA Grants Orphan Drug Designation to Pridopidine

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FDA Grants Orphan Drug Designation to Pridopidine

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Prilenia’s pridopidine for the treatment of amyotrophic lateral sclerosis (ALS). The decision follows a recent positive opinion from a branch of the European Medicines Agency recommending the treatment be given orphan drug status in Europe. A decision by the European Commission is expected soon. Orphan drug status is awarded to promote the development of treatments for rare and serious diseases. The designation…

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