Author Archives: Forest Ray PhD

Evrysdi Approved in Brazil for SMA, But No Indications Specified

Evrysdi (risdiplam) has been approved for the treatment of spinal muscular atrophy (SMA) in Brazil by the country’s National Health Surveillance Agency, known as ANVISA. The Brazilian approval came within seven months of Roche’s original submission, with the country becoming the second to approve the medicine,…

FDA Approves Catalent Facility to Aid in Zolgensma’s Production

The U.S. Food and Drug Administration (FDA) has given Catalent Biologics approval to aid in manufacturing products for use with AveXis’ spinal muscular atrophy (SMA) gene therapy, Zolgensma, at its Maryland facility. The FDA inspected the company’s commercial-scale gene therapy manufacturing center in June. Catalent and AveXis,…