Natalizumab Biosimilar to Get FDA Review for MS, Crohn Disease Indications
The application is under review for relapsing forms of multiple sclerosis and Crohn disease.
The application is under review for relapsing forms of multiple sclerosis and Crohn disease.
Stay up-to-date on the latest drugs in development.
Most neurological disorders do not appear to be more frequent after COVID-19 than after influenza or bacterial pneumonia
The RELEASE MSS1 trial included adults with a confirmed diagnosis of any disease subtype of multiple sclerosis.
The approval was based upon a bioavailability study in healthy adults comparing baclofen oral tablets to Lyvispah.
The FDA extended the action date to allow time to review a submission provided by the Company.
The Cionic Neural Sleeve is the first product to combine movement analysis and augmentation into a wearable garment.
The approval was based a bioavailability study comparing baclofen oral tablets with Fleqsuvy.
The product is available through a network of specialty pharmacies and distributors.
Risk for MS increased 32-fold following EBV infection, but not following infection with other viruses, including cytomegalovirus