HINOVA PHARMACEUTICALS INC. Hinova Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for HP518, an investigational drug for the treatment of Androgen-receptor positive (AR+) triple-negative breast cancer (TNBC). This designation is intended to expedite the development and review process for drugs that address serious conditions and fill an unmet medical need. FDA Fast Track Designation: The FDA's Fast Track program is designed to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need.
Fast Track designation enables more frequent communication with the FDA to discuss the drug's development plan and ensures eligibility for Accelerated Approval and Priority Review if relevant criteria are met.
