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 ...

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 ...

A healthcare company says it has secured an agreement with the U.S. Food and ...

Larimar announces nonclinical findings supporting nomlabofusp's mechanism of action and potential use as a surrogate endpoint for FDA approval. Larimar Therapeutics announced significant nonclinical ...

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 ...

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 MarketWatch News Department was not involved in the creation of this content. -- Measuring change in bone mineral density, rather than fracture occurrence, promises to speed development of new ...

Please provide your email address to receive an email when new articles are posted on . Patients who achieved undetectable measurable residual disease had a 72% reduced risk for disease progression or ...

Substantive data now support albuminuria change as a surrogate for a kidney failure endpoint in trials of drugs that affect albuminuria, across CKD etiologies. Albuminuria change can serve as a ...

The Foundation for the National Institutes of Health (FNIH) announces that the Food and Drug Administration (FDA) has qualified the treatment-related change in hip bone mineral density (BMD) as a ...