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Fast track is a designation by the United States Food and Drug Administration (FDA) of an investigational drug for expedited review to facilitate development of drugs that treat a serious or life-threatening condition and fill an unmet medical need. Fast track designation must be requested by the drug company.
CAMBRIDGE, Mass., Jan. 10, 2025 (GLOBE NEWSWIRE) -- Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, today announced the U.S. Food and Drug Administration (FDA) recently granted an additional Fast Track designation to ...
Small-cap cancer researcher GTx announced Tuesday that the U.S. Food and Drug Administration has granted "fast track" development status to its enobosarm (GTx-024) drug for the prevention and ...
FDA Grants QIDP and Fast Track Designations for Cubist's Late-Stage Antibiotic Candidates QIDP ... Qualifying pathogens are defined by the GAIN Act to include multi-drug resistant Gram ...
Saint Herblain (France) and Schlieren (Zurich), October 16, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and LimmaTech Biologics AG, a clinical-stage biotech company developing vaccines for the prevention of life-threatening diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Shigella4V (S4V ...
The company announced in July 2024, that the US Food and Drug Administration (FDA) had accepted a new drug application for suzetrigine. [11] The FDA granted the application for suzetrigine priority review, fast track, and breakthrough therapy designations. [2] [11] The FDA granted approval of Journavx to Vertex Pharmaceuticals. [2]
Abexinostat has been granted a fast track designation by the FDA for the treatment of patients with relapsed or refractory follicular lymphoma in the fourth-line setting. This designation is significant as it aims to expedite the development and review of drugs intended to treat serious conditions and fill an unmet medical need.
The FDA's "Fast Track" designation is intended to facilitate the development and expedite the review of potentially important new drugs and vaccines to treat or prevent serious conditions with ...