FDA qualification of Total Hip BMD as a validated surrogate endpoint for novel osteoporosis drug development further bolsters Entera's July 2025 ...

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 ...

Please provide your email address to receive an email when new articles are posted on . The FDA approval of Aduhelm, which was based on beta amyloid as a surrogate endpoint, represented a “regulatory ...

An analysis of the phase III NRG Oncology clinical trial RTOG 9601 on men receiving salvage radiotherapy (SRT) following prostatectomy for recurrent prostate cancer indicated that, while biochemical ...

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 ...

The surrogate endpoint offers an alternative to traditional fracture endpoints used in clinical trials of osteoporosis drugs ...

The FDA greenlights treatment-related changes in bone mineral density as a surrogate endpoint in anti-osteoporosis drug trials in postmenopausal women.

Phase 1b/2 study of margetuximab (M) plus pembrolizumab (P) in advanced HER2+ gastroesophageal junction (GEJ) or gastric (G) adenocarcinoma (GEA). Effects of apatinib dose interruptions on safety and ...

CARY, N.C., June 22, 2020 /PRNewswire/ -- Critical Path Institute (C-Path) announced Wednesday, June 17, that its Transplant Therapeutics Consortium (TTC), of which Veloxis Pharmaceuticals is a member ...

The Food and Drug Administration on Monday approved Biogen’s Alzheimer’s drug albeit to mixed reviews. In announcing its decision, the agency noted that the drug was granted "Accelerated Approval," ...