Pediatric Health

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Fennec Pharmaceuticals Completes Rolling Submission of NDA to U.S. FDA for Pedmark; Submits MAA to European Medicines Agency

Fennec Pharmaceuticals announced it has completed its rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Pedmark (a unique formulation of sodium thiosulfate) for intravenous use and submitted a Marketing Authorization...

Orchard Therapeutics Granted FDA Orphan Drug Designation for OTL-102 for X-linked Chronic Granulomatous Disease (X-CGD)

Orchard Therapeutics announced the U.S. FDA has granted Orphan Drug Designation for OTL-102, the company’s ex vivo autologous hematopoietic stem cell (HSC) gene therapy being investigated for the treatment of X-linked chronic granulomatous disease (X-CGD). The FDA may...

JAMA Neurology Publishes Data from Zogenix Phase 3 Trial Evaluating Fintepla in Patients with Dravet Syndrome Taking Stiripentol-Containing Antiepileptic Drug Regimens

Zogenix announced JAMA Neurology, has published the results of Zogenix’s Phase 3 Study 1504 which evaluated Fintepla (ZX008, fenfluramine oral solution) in Dravet syndrome patients whose antiepileptic drug treatment regimens included stiripentol but who were still...

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