Kyowa Hakko Kirin announced that the Food and Drug Administration (FDA) has accepted the resubmitted New Drug Application (NDA) for istradefylline (KW-6002) for use as adjunctive treatment to levodopa/carbidopa in adults with Parkinson disease (PD) experiencing OFF episodes. The NDA submission was rejected in 2008 due to concerns over efficacy findings. Istradefylline is an oral…
Celgene announced the submission of an NDA to the FDA for ozanimod for the treatment of relapsing forms of multiple sclerosis in adults.
Avanir announced data from the phase 3 clinical program that evaluated AVP-786 (deudextromethorphan hydrobromide/quinidine sulfate) for the treatment of moderate-to-severe agitation in patients with Alzheimer dementia.
The FDA has approved Sunosi to improve wakefulness in adults with excessive daytime sleepiness associated with narcolepsy or OSA.
Results from a real-world study evaluating rivaroxaban (Xarelto; Janssen) in newly diagnosed patients with nonvalvular atrial fibrillation (NVAF) were presented at the American College of Cardiology’s (ACC) 68th Annual Scientific Session.
Alexion announced the publication of data from the phase 3 open-label extension of the REGAIN trial (ECU-MG-302) that assessed the long-term safety and efficacy of eculizumab (Soliris) for the treatment of adults with anti-acetylcholine receptor (AChR) antibody-positive refractory generalized myasthenia gravis (gMG).
Allergan announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application for ubrogepant, a highly potent oral calcitonin gene-related peptide (CGRP) receptor antagonist, for the acute treatment of migraine in adults.
Allergan announced that the Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Applications (sBLAs) for Botox (onabotulinumtoxinA) injection for the treatment of patients aged ≥2 years with upper and lower limb spasticity.