Following planned data collection, DURIPANC Primary Endpoint analysis is anticipated to begin in December 2026 and topline results are anticipated in Q1 2027. DURIPANC’s primary endpoint is Clinical ...

First patients dosed at City of Hope and the University of Alabama at BirminghamDOC-RM recently featured as a ...

Clinical data from the HERCULES trial show that tolebrutinib reduces six-month confirmed disability progression by 31% in non ...

Agency staff and drug developer disagree on endpoints ...

Mayo Clinic researchers have identified a protein that cancer cells use to shut down the body's immune response, a discovery that could help scientists develop new treatments that make cancer ...

The FDA's Cellular, Tissue, and Gene Therapies Advisory Committee voted 10-3 in favor of the IGNYTE study (NCT03767348) supporting the potential accelerated approval of vusolimogene oderparepvec (RP1; ...

The new approach to testing improves diagnostic accuracy, reduces clinically irrelevant findings, and decreases false positives.

FDA aligned on new-onset severe respiratory failure as the Phase 2b primary endpoint, with multi-organ failure and time to medically indicated discharge as key secondary ...

The gut mucosa is no longer viewed merely as a site of digestion and defense; it is now recognized as a central orchestrator ...

Chronic hepatitis B (CHB) remains a major global challenge. Current therapies suppress HBV but rarely achieve functional cure ...

This indication is approved under accelerated approval based on reduction of proteinuria. It has not been established whether VOYXACT slows kidney function decline over the long-term in patients with ...

CTGTAC endorsed that single-arm Ignyte response rate and durability support clinically meaningful systemic antitumor activity attributable to intratumoral RP1 combined with nivolumab in ...