Emflaza Approved for Younger Patients With Duchenne Muscular Dystrophy
The FDA has approved an expanded indication for Emflaza (deflazacort; PTC Therapeutics, Inc.) to include children 2 to 5 years of age with Duchenne muscular dystrophy.
All articles by Brian Park, PharmD
Emgality Approved to Treat Episodic Cluster Headache in Adults
The FDA has approved Emgality (galcanezumab-gnlm; Lilly) for injection for the treatment of episodic cluster headache in adults.
FDA: Company Promoting Unapproved Stem Cell Products for ALS, Parkinson Disease and Other Serious Conditions
The FDA has sent an untitled letter to R3 Stem Cell, LLC of Scottsdale, Arizona for marketing unapproved stem cell products to treat a variety of diseases and conditions.
First Gene Therapy for Pediatric Patients With Spinal Muscular Atrophy Gets FDA Approval
The FDA has approved Zolgensma (onasemnogene abeparvovac-xioi; Novartis) for the treatment of children less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene.
Phase 3 Study Results Announced for Pregabalin in Primary Generalized Tonic-Clonic Seizures
A phase 3 study assessing the use pregabalin as adjunctive therapy for epilepsy patients 5 to 65 years of age with primary generalized tonic-clonic (PGTC) seizures did not meet its primary endpoint to reduce seizure frequency compared with placebo.
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