The FDA approved Scancell's phase 3 trial of iSCIB1+ for advanced melanoma, focusing on progression-free survival as a ...
Time to deterioration of physical function showed "meaningful superiority" over progression-free survival (PFS) as an early surrogate for overall survival in trials of immune checkpoint inhibitors ...
In the FDA’s push to grant accelerated approvals to treatments that can help patients in need, the agency has become increasingly reliant on the use of surrogate markers (or “proxies”), which can ...
Life in the Fast Lane: FDA Issues New Draft Guidance for Accelerated Approval of Drugs and Biologics
In 1976, the Eagles released the song, “Life in the Fast Lane,” as part of their iconic album, Hotel California. Approximately 16 years later, the Food and Drug Administration began offering ...
Please provide your email address to receive an email when new articles are posted on . FDA panel advised MRD is an acceptable endpoint for accelerated approval of new treatments for multiple myeloma.
Minimal residual disease was “strongly” associated with overall survival at the patient level, researchers reported. Minimal residual disease (MRD) is “a credible intermediate endpoint” for some ...
JERUSALEM, March 26, 2024 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (ENTX) (“Entera” or the “Company”), a leader in the development of orally delivered peptides, announced today that The American Society ...
The U.S. Food and Drug Administration (FDA) has cleared an investigational new drug application for a registrational phase 3 clinical trial of iSCIB1+ for patients with advanced melanoma, a step that ...
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