Novel Therapy for Progressive Supranuclear Palsy Gets Orphan Drug Designation
The FDA has granted Orphan Drug designation to RT001 (Retrotope) for the treatment of progressive supranuclear palsy (PSP).
The FDA has granted Orphan Drug designation to RT001 (Retrotope) for the treatment of progressive supranuclear palsy (PSP).
The Food and Drug Administration (FDA) has accepted for review the New Drug Application for Libervant® (diazepam; Aquestive Therapeutics) buccal film for the management of seizure clusters.
The Food and Drug Administration (FDA) has granted Orphan Drug designation to PIC1-dPEG24 (ReAlta Life Sciences) for the treatment of hypoxic-ischemic encephalopathy (HIE) in neonates.
Risdiplam is an investigational, orally administered liquid survival motor neuron-2 (SMN2) splicing modifier designed to increase and sustain SMN protein levels throughout the central nervous system and peripheral tissues of the body.
The Food and Drug Administration (FDA) has approved updates to the prescribing information for Belsomra® (suvorexant; Merck) to include study findings for the treatment of insomnia in patients with mild to moderate Alzheimer disease.
A PDUFA target date of June 30, 2020 has been assigned to the application.
Akili Interactive announced topline data from an open-label study (STARS-ADHD Adjunctive) of AKL-T01 for the treatment of attention deficit hyperactivity disorder in children with or without use of stimulants.
Taro Pharmaceuticals announced the voluntary recall of 1 lot of lamotrigine 100mg tablets to the consumer level due to cross-contamination with a small amount of enalapril maleate.
The FDA has approved lemborexant for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance in adult patients.
The Food and Drug Administration (FDA) has approved Ubrelvy (ubrogepant tablets; Allergan), the first oral calcitonin gene-related peptide (CGRP) receptor antagonist, for the acute treatment of migraine with or without aura in adults.