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437,188 Results for "endpoint health".
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Brain cancer
Imvax Heads to FDA With 6-Month Survival Gain in Glioblastoma, Despite Endpoint Miss
While Imvax’s autologous immunotherapy IGV-001 missed the primary endpoint of progression-free survival in a Phase IIb trial, the company will request a meeting with the FDA to discuss next steps for “synergistic” treatment.
December 2, 2025
·
2 min read
·
Dan Samorodnitsky
Regulatory
FDA’s Tidmarsh Singles Out Aurinia’s Drug in LinkedIn Post About Surrogate Endpoints
Without naming Aurinia Pharmaceuticals, the CDER director in a now-deleted LinkedIn post claimed that for lupus nephritis, companies have not conducted post-approval studies “to demonstrate a benefit on hard clinical endpoints.”
September 30, 2025
·
2 min read
·
Tristan Manalac
Lymphoma
AbbVie, Genmab’s Bispecific Misses Key Overall Survival Endpoint in Phase III Lymphoma Study
Despite the late-stage miss, analysts maintained confidence in the Epkinly program, with Truist Securities saying the result “doesn’t waver our optimism” regarding the bispecific antibody’s ongoing frontline trial.
January 19, 2026
·
2 min read
·
Tristan Manalac
Press Releases
Optimi Health Completes First 2026 Production of MDMA and Psilocybin Capsules
Australia’s Department of Health has issued import permits for Optimi’s MDMA and psilocybin capsules for use under the Authorised Prescriber Scheme
January 26, 2026
·
1 min read
Press Releases
As mental health patients turn to AI chatbots, how can pharma lead the way?
A new report by Bryter released today reveals where pharma can lead as patients turn to (and question) AI tools for mental health.
February 5, 2026
·
1 min read
Press Releases
Press Release: Sanofi’s venglustat met all primary endpoints in a phase 3 study of type 3 Gaucher disease
February 2, 2026
·
11 min read
Press Releases
PDS Biotech Announces FDA Alignment on use of Progression Free Survival (PFS) as Primary Endpoint
January 9, 2026
·
6 min read
Press Releases
Beacon Biosignals Announces Partnership with Harmony Biosciences to Advance Objective Clinical Endpoints in Hypersomnia Conditions Through Quantitative EEG
December 16, 2025
·
3 min read
Press Releases
Privo Technologies Announces Milestone in PRV211 Arm of CLN-004 Clinical Trial: Primary Endpoint Met; No Serious Adverse Events Reported
January 26, 2026
·
3 min read
Press Releases
RSNA25: Pediatric Study for Bayer’s Investigational MRI Contrast Agent Gadoquatrane Meets Primary and Secondary Endpoints
December 4, 2025
·
6 min read
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