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Amylyx Pharmaceuticals, Inc.

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Latest From Amylyx Pharmaceuticals, Inc.

FDA’s New PSG Batch Features GSK’s Inhalers

In its latest batch of product-specific guidances, the FDA released multiple new and revised guidances on inhalers, including several on GSK’s products such as Relenza and the Ellipta trio.

United States Guidance Documents

Eisai Refiles Mecobalamin For ALS In Japan After Seven Years

Additional studies have shown an ultra-high dose of mecobalamin safely decreased ALS progression in early-stage patients by 43%. Japan has spent decades studying the drug’s efficacy for the disease.

Japan Rare Diseases

Confirmatory Evidence: FDA Guidance Allowance For Use Of Animal Data Draws Split Views

Industry comments also seek more specificity on the types of real-world data that could supplement a single adequate and well-controlled trial to demonstrate substantial evidence of efficacy, and clarification as to whether confirmatory evidence can come from the same single clinical study.

Drug Approval Standards Guidance Documents

BrainStorm Eyes New Phase III Trial For NurOwn In Mild ALS Following BLA Withdrawal

Highly negative FDA advisory committee review and subsequent discussions with the agency made clear the only path forward was a new study, company executives said. Troubled application shows the limits of FDA’s willingness to exercise regulatory flexibility.

Drug Review Regenerative Medicine
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