Nanobiotix Amends NANORAY-312 Trial Design, Eliminates Interim Analysis
Johnson & Johnson amends NANORAY-312 trial design, eliminating interim analysis and accelerating the final efficacy readout in head and...
Ersodetug Shows Strong Hypoglycemia Reductions in Congenital Hyperinsulinism Trial
Ersodetug shows 50-80% reductions in hypoglycemia time in congenital hyperinsulinism trial, with strong patient retention in open-label extension.
Atsena’s ATSN-201 Achieves Foveal Schisis Closure in 67% of Adults With X-linked Retinoschisis
Atsena's ATSN-201 achieved foveal schisis closure in 67% of adults with X-linked retinoschisis at six months, with clean pediatric...
Cellenko’s CK0802 Advances to Phase 1b/2a Trial for Steroid-Refractory GVHD
Cellenko's CK0802, an off-the-shelf cord blood Treg therapy, advances to Phase 1b/2a trial for steroid-refractory GVHD with Day 29...
FDA Approves Arvinas’ Vepdegestrant for ESR1-Mutant Breast Cancer
FDA approves Arvinas vepdegestrant for ESR1-mutant breast cancer, showing 5.0-month median PFS versus 2.1 months with fulvestrant in pivotal...
When J&J Eliminates the Interim: What the NANORAY-312 Amendment Actually Signals
J&J's FDA-accepted protocol amendment to NANORAY-312 drops the interim analysis for NBTXR3—here's what that move reveals about pivotal trial...
Semaglutide Just Changed the Math on Alcohol Use Disorder — and Every Addiction Trial Sponsor Should Be Paying Attention
A Lancet RCT shows once-weekly semaglutide cut heavy drinking days in obese AUD patients — targeting a condition where...
Semaglutide’s Alcohol Data Is Stronger Than Anyone Expected — and the FDA Has No Playbook for It
A landmark Lancet RCT shows once-weekly semaglutide cuts alcohol use in obesity patients with AUD. The FDA's regulatory pathway...
Cocrystal’s CDI-988 Enters Phase 1b Human Challenge Study for Norovirus
CDI-988 Phase 1b study launches at Emory with human challenge model for norovirus, testing both prevention and treatment in...
Vosoritide Shows 13.6 cm Height Gain Over Eight Years in Achondroplasia
Vosoritide demonstrated 13.6 cm height gain over eight years in achondroplasia, with sustained bone health and proportional skeletal growth...