The U.S. Food and Drug Administration approved Deciphera Pharmaceuticals Inc.’s Qinlock (ripretinib) for the treatment of adult patients with advanced gastrointestinal stromal tumor who have received prior treatment with 3 or more kinase inhibitors, including imatinib.
The U.S. Food and Drug Administration granted Fast Track designation for Neuraptive Therapeutics Inc.’s franchise therapeutic product, NTX-001, in the treatment of patients with peripheral nerve injuries.
The U.S. Food and Drug Administration granted “fast track” designation to Moderna Inc.’s experimental coronavirus vaccine, a move that speeds up the regulatory review process.
MultiStem, a cell therapy in development at Athersys, was recently designated “Highly Relevant” as a Potential Therapy for COVID-19 by BARDA. This is the only therapy in development that targets acute respiratory distress syndrome (ARDS), the pneumonia-like condition that leads to severe illness and death among COVID-19 patients, and is the only one ARDS therapy that has also received Fast Track designation from the FDA.
Three months after winning FDA approval in type 2 diabetes, AstraZeneca is eyeing a potential U.S. regulatory win for Farxiga as a treatment in heart failure patients.
The U.S. FDA approved Celgene and Acceleron Pharma’s Reblozyl for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.
The U.S. Food and Drug Administration granted fast track status for the development of AstraZeneca’s diabetes drug Farxiga to prevent heart and kidney failure in patients with chronic kidney disease.
The U.S. FDA gave Nabriva Therapeutics a thumbs-up for the company’s oral and intravenous formulations of Xenleta (lefamulin) to treat community-acquired bacterial pneumonia in adults.
RedHill Biopharma Ltd. announced that the U.S. Food and Drug Administration accepted for review the New Drug Application for Talicia (RHB-105) for H. pylori infection.
Cellectar Biosciences Inc. announced that the U.S. Food and Drug Administration granted Fast Track Designation for CLR 131 in fourth line or later relapse/refractory multiple myeloma.