The Food and Drug Administration (FDA) has approved the Senza Omnia Spinal Cord Stimulation (SCS) System (Nevro) for the treatment of chronic intractable pain of the trunk and/or limbs.
Apadaz (benzhydrocodone and acetaminophen immediate-release tablets) and its authorized generic AG-Apadaz will be available nationally beginning in November 2019.
The FDA has accepted the Biologics License Application (BLA) for satralizumab (Genentech) for the treatment of neuromyelitis optica spectrum disorder.
Nourianz is now available as an adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson disease (PD) experiencing “off” episodes.
Positive data from phase 2 study of Spinraza for preventing or delaying the need for respiratory intervention or death in infants with genetically diagnosed and presymptomatic spinal muscular atrophy.
Tosymra (sumatriptan; Upsher Smith Laboratories) Nasal Spray is now available for the acute treatment of migraine with or without aura in adults.
The FDA and the Drug Enforcement Administration (DEA) have issued joint warning letters to several website operators that have been illegally selling opioid medications online.
Results of a safety review have led to the discontinuation of phase 3 clinical studies of elenbecestat, an investigational oral BACE (beta amyloid cleaving enzyme) inhibitor, which was being assessed for early Alzheimer disease (AD) treatment.
A phase 3 trial evaluating pimavanserin (Acadia) for the treatment of dementia-related psychosis has been stopped early due to positive findings in a planned interim efficacy analysis.
The FDA has granted Orphan Drug designation to an investigational therapy for the treatment of amyotrophic lateral sclerosis.
