AbobotulinumtoxinA Indication Expanded to Include Upper Limb Spasticity Treatment in Children
Dysport is indicated for the treatment of both upper and lower limb spasticity in children aged 2 years and older.
All articles by Brian Park, PharmD
Investigational Treatment for Guillain-Barré Syndrome Gets Fast Track Status
The FDA has granted Fast Track designation to ANX005 for the treatment of Guillain-Barré Syndrome, an autoimmune disease that can lead to widespread peripheral nerve damage and paralysis.
Ponesimod Superior to Teriflunomide in Relapsing MS Trial
Janssen announced results from the phase 3 OPTIMUM study comparing treatment with ponesimod vs teriflunomide in patients with relapsing multiple sclerosis.
Zilucoplan for Myasthenia Gravis Gets Orphan Drug Designation
The Food and Drug Administration has granted Orphan Drug designation to zilucoplan for the treatment of generalized myasthenia gravis and other rare, tissue-based complement-mediated diseases.
FDA to Review Inebilizumab for Neuromyelitis Optica Spectrum Disorder
The Food and Drug Administration has accepted for review the Biologics License Application for inebilizumab for the treatment of patients with neuromyelitis optica spectrum disorder.
FDA Approves New Adjunct Treatment for Parkinson Disease
The Food and Drug Administration (FDA) has approved Nourianz (istradefylline; Kyowa Kirin) tablets as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson disease (PD) experiencing “off” episodes.
Cell Therapy Receives Fast Track Status for Degenerative Disc Disease
The FDA has granted Fast Track designation for IDCT (DiscGenics, Inc.), an investigational cell therapy for the reduction in pain and disability associated with degenerative disc disease (DDD).
FDA Denies Approval of Investigational Treatment for Duchenne Muscular Dystrophy
The FDA has issued a complete response letter to Sarepta Therapeutics regarding the NDA for golodirsen, an investigational treatment for patients with Duchenne muscular dystrophy with a confirmed mutation amenable to exon 53 skipping.
Trial Investigating Treatment for Hyperammonemia in Cirrhosis Discontinued
Synologic, Inc announced that following disappointing top-line data from a phase 1b/2a study, the Company will discontinue the development of SYNB1020 for the treatment of hyperammonemia.
FDA Approves Pitolisant for Excessive Daytime Sleepiness in Adults With Narcolepsy
Wakix is a selective H3 receptor antagonist/inverse agonist and the first treatment for narcolepsy that is not scheduled as a controlled substance.
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