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Coherus has revealed that UDENYCA ONBODY™, an innovative and advanced technology for administering pegfilgrastim-cbqv, has received authorization from the FDA.
Fast track designation (FTD) is a process used by the U.S. Food and Drug Administration (FDA) tofacilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
Zealand Pharma has officially presented a request for drug approval to the United States' FDA for their medication glepaglutide, aiming to treat individuals with short bowel syndrome.
The U.S. FDA offers Fast Track Designation and Breakthrough Therapy Designation to speed up the development and review of drugs for serious conditions lacking treatments. Yet, they differ in key aspects.