April 25th 2025
Approval of penpulimab-kcqx marks the company’s US regulatory debut and introduces a new immunotherapy option for advanced nasopharyngeal carcinoma.
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.
Approval of Eli Lilly's Alzheimer Drug Donanemab Delayed as FDA Seeks More Information
March 8th 2024Because of the unique trial design of the Phase III TRAILBLAZER-ALZ 2 study, the FDA is seeking additional input regarding the safety and efficacy of donanemab for the treatment of early symptomatic Alzheimer disease.