Fizurex advances toward human trials as Steel Therapeutics completes pivotal safety study
Discover how Steel Therapeutics’ Fizurex toxicology milestone could reshape anal fissure treatment as the program advances toward an FDA IND.
Pharma & Biotech
Medical Devices & Diagnostics
Can GE HealthCare’s Allia upgrades modernize interventional suites without full replacement?
Find out how GE HealthCare’s Allia upgrade pathways could modernize aging interventional suites while limiting downtime and construction.
Pharma & Biotech
Why Biocytogen’s RenNano court win could shift the race for fully human VHH antibodies
Discover how Biocytogen’s RenNano court win could reshape VHH antibody licensing, platform risk and next-generation biologics development.
Pharma & Biotech
Can Neurogene’s NGN-401 restart developmental progress in patients with Rett syndrome?
Long-term Phase 1/2 data suggest that Neurogene’s NGN-401 gene therapy may produce continuing developmental gains across several functional domains in Rett syndrome. The small, uncontrolled dataset remains preliminary, however, leaving the larger Embolden registrational trial to determine whether those improvements are reproducible, clinically persuasive and sufficient for regulatory approval.
Pharma & Biotech
Cogent advances third bezuclastinib FDA submission after APEX pivotal trial results
Cogent’s bezuclastinib NDA for advanced systemic mastocytosis is backed by APEX data showing 65% ORR and deep KIT-driven disease marker reductions.
Pharma & Biotech
Zambon’s Hopledo wins CHMP backing, but can fewer daily doses reshape Parkinson’s care?
See how Zambon’s Hopledo could change Parkinson’s motor fluctuation care in Europe after a positive CHMP opinion, and what risks remain.
Pharma & Biotech
Zura Bio bets on dual IL-17 and BAFF inhibition across three immune-mediated disease
Explore how Zura Bio’s expanded tibulizumab Phase 2 program could change treatment development in HS and systemic sclerosis.
Pharma & Biotech
Russell 2000 inclusion puts Precision BioSciences before more investors at a pivotal clinical stage
See how Russell 2000 inclusion expands Precision BioSciences’ investor reach while PBGENE-HBV and PBGENE-DMD face critical clinical tests.
Pharma & Biotech
Samsung Bioepis SB27 meets Phase 3 endpoint as Keytruda biosimilar competition accelerates
Read how Samsung Bioepis SB27’s positive Phase 1 and Phase 3 data could reshape the Keytruda biosimilar race and oncology access.
Pharma & Biotech
Covista links scholarships, clinical training and employment in Advocate Health nursing deal
Explore how Covista and Advocate Health’s nursing pipeline could reshape workforce readiness, retention and patient access across U.S. care.