Selecta Biosciences said that the US Food and Drug Administration (FDA) has imposed a clinical hold on its phase 1/2 clinical trial of SEL-302 gene therapy for the treatment of methylmalonic acidemia (MMA). SEL-302 consists of MMA-101 plus ImmTOR immune tolerance platform. The US-based biotech company said that it has been sent a letter from […]
In a major advancement for hemophilia A therapy, Bayer’s recombinant factor VIII (rFVIII) replacement therapy, Jivi (BAY94-9027), has received approval from the U.S. Food and Drug Administration (FDA) for routine preventative treatment in individuals aged 12 years and older. This approval marks Jivi as the third hemophilia A treatment drug from Bayer to gain FDA […]