BioSpace News Archive

Genetown

European Commission Approves KAFTRIO® in Combination With Ivacaftor for the Treatment of Children With Cystic Fibrosis Ages 2 Through 5

Vertex Pharmaceuticals Incorporated announced that the European Commission has granted approval for the label expansion of KAFTRIO® in a combination regimen with ivacaftor for the treatment of children with cystic fibrosis ages 2 through 5 years old who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator gene.

November 23, 2023
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10 min read
Drug Development

Medicure Announces FDA Provides Complete Approval to Enroll Patients in Its Pivotal Phase 3 Trial for Treatment of Rare Pediatric Disease

Medicure Inc. announced that the FDA provides complete approval to enroll patients in its pivotal Phase 3 clinical trial to evaluate the use of its investigational product MC-1 for treatment of a rare pediatric disease called pyridoxine 5′-phosphate oxidase deficiency.

November 23, 2023
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6 min read
Policy

China’s First NDA for a KRAS G12C Inhibitor: Innovent Announces the National Medical Products Administration of China Has Accepted and Granted Priority Review Designation to the New Drug Application for IBI351

Innovent Biologics, Inc. announces that the New Drug Application for IBI351 has been accepted by the Center for Drug Evaluation of the National Medical Products Administration of China and granted Priority Review designation[1], for the treatment of patients with advanced non-small cell lung cancer harboring KRAS G12C mutation who have received at least one systemic therapy.

November 23, 2023
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9 min read