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.
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.
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).
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.
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.
Wakix is a selective H3 receptor antagonist/inverse agonist and the first treatment for narcolepsy that is not scheduled as a controlled substance.
The FDA has concluded that the use of entacapone to treat Parkinson disease (PD) does not increase the risk of developing prostate cancer.
The Food and Drug Administration has granted Orphan Drug designation to STK-001 (Stoke Therapeutics) for the treatment of Dravet syndrome.
Janssen announced positive top-line results from the phase 3 OPTIMUM study of ponesimod in adult patients with relapsing multiple sclerosis.
