Zavzpret (zavegepant) nasal spray is now available for the acute treatment of migraine with or without aura in adults.
All articles by Brian Park, PharmD
The FDA has approved Rystiggo (rozanolixizumab-noli) for the treatment of generalized myasthenia gravis in adults.
The FDA has approved Elevidys (delandistrogene moxeparvovec-rokl) for ambulatory pediatric patients 4 to 5 years of age with DMD.
An FDA committee voted unanimously that lecanemab-irmb (Leqembi) shows clinical benefit for the treatment of Alzheimer disease.
The FDA has approved Abrysvo for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older.
Lumryz (sodium oxybate) is now available for the treatment of cataplexy or excessive daytime sleepiness in adults living with narcolepsy.
The FDA has granted Fast Track designation to isaralgagene civaparvovec (ST-920) for the treatment of Fabry disease.
The FDA has granted Fast Track designation to milvexian across 3 indications including ischemic stroke, ACS, and atrial fibrillation.
The FDA has accepted for review the NDA for STS101 (dihydroergotamine nasal powder) for the acute treatment of migraine.
Consumers are being warned not to purchase or use Nose Slap or Soul Slap as these products primarily contain ammonia.
Akorn ceased and shutdown all operations following a Chapter 7 bankruptcy filed on February 23, 2023.
The FDA has approved Qalsody (tofersen) for the treatment of adults with ALS who have a mutation in the SOD1 gene.
The FDA has expanded the approval of Qulipta (atogepant) to include the preventive treatment of chronic migraine in adults.
Daybue (trofinetide) is now available for the treatment of Rett syndrome in adult and pediatric patients 2 years of age and older.
UCB has filed a labeling supplement with the FDA to remove the Schedule IV designation.
With RizaFilm oral films, administration with liquids is not necessary.
The FDA has granted Fast Track designation to RGX-202 for the treatment of Duchenne muscular dystrophy (DMD).
The trial met the criteria for futility and is being discontinued.
The FDA panel voted in favor of tofersen for accelerated approval in patients with superoxide dismutase 1 amyotrophic lateral sclerosis.
Zavzpret (zavegepant) nasal spray is a calcitonin gene-related peptide (CGRP) receptor antagonist.
Solanezumab is a humanized monoclonal antibody designed to increase clearance of soluble amyloid beta (Aβ) from the brain by binding to aggregated forms of Aβ.
The sBLA is supported by data from the confirmatory phase 3 Clarity AD trial, which included patients with early Alzheimer disease.
Nerivio is a wireless remote electrical neuromodulation (REN) device designed to be self-applied to the upper arm.
Skyclarys activates the Nrf2 pathway which is involved in the cellular response to oxidative stress.
Austedo XR is a vesicular monoamine transporter 2 inhibitor.
The Company is currently evaluating the efficacy and safety of taldefgrobep alfa in patients with SMA in the phase 3 RESILIENT study.
Tascenso ODT is a sphingosine 1-phosphate receptor modulator.
Gadopiclenol only requires half of the gadolinium dose of conventional nonspecific GBCAs.
The Company has completed a phase 2 trial which evaluated the efficacy and safety of oral ketamine in patients with Rett syndrome.
AOC 1020 is designed to reduce the expression of DUX4 mRNA and DUX4 protein in muscles.
