SRPT Forex News
Quest Diagnostics Says FDA Grants Breakthrough Designation For Adeno-associated Virus Test
Quest Diagnostics (DGX), a diagnostic information services provider, announced Wednesday that its AAVrh74 ELISA assay (CDx) has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).
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426 days ago
FDA OKs Elevidys As First Gene Therapy To Treat Duchenne Muscular Dystrophy
Sarepta Therapeutics, Inc. announced Friday that the U.S. Food and Drug Administration or FDA has accelerated approval of ELEVIDYS (delandistrogene moxeparvovec-rokl) for the treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene.
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494 days ago
Sarepta Therapeutics Updates Of BLA For Sarepta's Duchenne Muscular Dystrophy Drug Candidate
Sarepta Therapeutics, Inc. (SRPT) on Wednesday provided the following update on the Biologics License Application (BLA) for SRP-9001 (delandistrogene moxeparvovec), which is currently under review for the treatment of ambulant individuals with Duchenne muscular dystrophy (DMD) who have a confirmed mutation of the DMD gene.
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524 days ago
Sarepta Submits BLA For SRP-9001 To Treat Ambulant Patients With Duchenne Muscular Dystrophy
Genetic medicine maker Sarepta Therapeutics, Inc. (SRPT) announced Thursday that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the accelerated approval of SRP-9001 (delandistrogene moxeparvovec) to treat ambulant patients with Duchenne muscular dystrophy.
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761 days ago
Sarepta Therapeutics Says FDA Lifts Clinical Hold On SRP-5051 To Treat Duchenne Muscular Dystrophy
Genetic medicine maker Sarepta Therapeutics, Inc. (SRPT) announced Tuesday that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on SRP-5051 (vesleteplirsen), the Company's investigational, next-generation peptide-conjugated phosphorodiamidate morpholino oligomer (PPMO) to treat patients with Duchenne muscular dystrophy who are amenable to exon 51 skipping.
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784 days ago
