May 16th 2024
This is the second accelerated approval the FDA has granted to Bristol Myers Squibb’s chimeric antigen receptor T-cell therapy in the past few months.
FDA Approves Italfarmaco SpA’s Duvyzat for Duchenne Muscular Dystrophy
March 22nd 2024Duvyzat (givinostat) is histone deacetylase inhibitor that was previously granted priority review, orphan drug designation, and rare pediatric disease designation by the FDA for patients 6 years of age and older with Duchenne muscular dystrophy.
FDA Approves Johnson & Johnson’s Edurant PED for Pediatric Patients With HIV
March 20th 2024Expanded indication for Edurant in combination with other antiretroviral therapies includes treatment-naïve children with HIV-1 RNA <100,000 copies/mL aged at least 2 years and weighing between 14 kg and 25 kg.