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Pharmaceutical Technology on MSNEC grants orphan drug designation to Dyne Therapeutics’ DMD therapyThe company anticipates submitting a biologics licence application for accelerated approval in the US in early 2026.
The FDA has granted Orphan Drug Designation to NeuroNOS's BA-102 ... which may lead to skepticism about the viability of the treatment. The timeline for initiating first-in-human U.S. clinical ...
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