FDA accepts for priority review a Merck supplemental BLA for Winrevair (sotatercept-csrk), seeking to update its label to reflect new data showing a significant reduction in mortality and morbidity.
FDA issues Capricor Therapeutics a complete response on its BLA for Deramiocel, a cell therapy candidate targeting cardiomyopathy associated with Duchenne muscular dystrophy.
FDA accepts for priority review a Merck supplemental BLA for Winrevair (sotatercept-csrk), seeking to update its label to reflect new data showing a significant reduction in mortality and morbidity.
FDA issues Capricor Therapeutics a complete response on its BLA for Deramiocel, a cell therapy candidate targeting cardiomyopathy associated with Duchenne muscular dystrophy.
FDA clears an Intuitive 510(k) for its Vessel Sealer Curved advanced energy instrumentation for use with its multiport da Vinci systems.
FDA announces a 9/19 scientific workshop to discuss the development of interchangeable biosimilar products to help identify future needs (e.g., guidance, research).
