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Regulatory tracker: FDA sets decision date for Sarepta's DMD drugs
Welcome to Fierce Pharma's regulatory tracker for the second half of 2026. | In this tracker, Fierce Pharma is recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Some of these updates may not meet the bar for standalone stories, but we think they are still worth mentioning.
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benzinga.com
Sarepta Moves Closer To FDA Approval For Duchenne Muscular Dystrophy Drugs - Sarepta Therapeutics (NASDAQ
FDA accepts Sarepta's filings seeking traditional approval for AMONDYS 45 and VYONDYS 53, with a decision expected by February 2027.
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fiercepharma.com
Regulatory tracker: FDA sets decision date for Sarepta's DMD drugs
Welcome to Fierce Pharma's regulatory tracker for the second half of 2026. | In this tracker, Fierce Pharma is recording the regulatory progress of in-market products, including…