On Dec 19, 2025, the US Food and Drug Administration (FDA) announced a major milestone by qualifying total hip bone mineral density (BMD), assessed by dual-energy X-ray absorptiometry, as a surrogate ...

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 ...

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.

Spruce Biosciences, Inc. (Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need ...

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 ...

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 ...

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 ...

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 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 ...