Pharma Journalist - Page 90 of 834 -

Solid Biosciences Receives FDA IND Clearance for Dual Route Gene Therapy in Friedreich’s Ataxia

FDA Granted Priority Review to Dizal’s Sunvozertinib New Drug Application

Amgen’s IMDYLLTRA Granted Conditional Approval for Small Cell Lung Cancer in UK

Vaxcyte’s VAX-24 IND Cleared by FDA for Prevention of Invasive Pneumococcal Disease in Infants

FDA Accepts Alnylam’s Supplemental NDA for ONPATTRO (patisiran) to Treat Cardiomyopathy in ATTR Amyloidosis

Pfizer’s RSV Maternal Vaccine Candidate BLA Accepted by FDA for Priority Review

Pozelimab (C5 Antibody) BLA for Treatment of Children and Adults with Ultra-rare CHAPLE Disease Accepted for FDA Priority Review

UK Grants Full Marketing Authorization to Karyopharm and Menarini Group’s NEXPOVIO for Multiple Myeloma Treatment

FDA has granted fast track designation to Biohaven’s Taldefgrobep Alfa for the treatment of spinal muscular atrophy

FDA Accepts Valneva’s Chikungunya Vaccine License Application for Priority Review

Clover Enters into Exclusive Agreement to Commercialize Quadrivalent Seasonal Influenza Vaccine in Mainland China

First Gene Therapy for Hemophilia B, CSL’s HEMGENIX, Approved by the European Commission

Capricor Therapeutics and Nippon Shinyaku Form Partnership for CAP-1002 Distribution in Japan, Treating Duchenne Muscular Dystrophy