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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.
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 ...
Drug approval typically requires clinical trials with endpoints that demonstrate a clinical benefit, such as increased survival for cancer patients. Drugs with accelerated approval can initially be tested in clinical trials that use a surrogate endpoint, or something that is thought to predict clinical benefit.
On November 23, 2018, CytoDyn received FDA approval of its IND submission and allowed to initiate a Phase 1b/2 clinical trial for metastatic triple-negative breast cancer (mTNBC) patients. In May 2019, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for Leronlimab (PRO 140) for use in combination with carboplatin for ...
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The FDA grants a Fast Track designation to Spectrum Pharmaceuticals' (SPPI) poziotinib for treating non-small cell lung cancer in previously treated patients with HER2 exon 20 mutations.
The U.S. Food and Drug Administration (FDA) granted the application for sotorasib orphan drug, fast track, priority review, and breakthrough therapy designations. [5] [10] The FDA granted approval of Lumakras to Amgen Inc. [5] Sotorasib was approved under the FDA's accelerated approval program. [19]
FDA Grant Fast Track Designation to ELND005 for the Treatment of Neuropsychiatric Symptoms in Alzheimer's Disease DUBLIN, Ireland--(BUSINESS WIRE)-- Elan Corporation, plc (NYS: ELN) announced ...