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Policy
New UK/EU Rules and AI Adoption Define CRO Priorities for 2026
With new UK clinical trial rules landing in 2026, the EU Biotech Act on the horizon and China and Australia gaining ground, CROs are zeroing in on study timelines, AI/ML and data privacy as the industry’s next pressure points.
December 3, 2025
·
4 min read
·
Jennifer Smith-Parker
Press Releases
Microbiome Labs Launches DigestMate, a 2-in-1 Digestive Enzyme and Probiotic Formula
December 3, 2025
·
2 min read
Duchenne muscular dystrophy
Capricor Heads Back to FDA With Pivotal Results for DMD Cardiomyopathy Therapy
Six months after receiving a surprise rejection due to what the FDA called “lack of substantial evidence of effectiveness,” Capricor’s cell therapy deramiocel showed significant benefits in upper-limb function and slowed decline in cardiac function in a Phase III trial.
December 3, 2025
·
3 min read
·
Heather McKenzie
Press Releases
VectorY Therapeutics Receives FDA Clearance of IND to Proceed with the PIONEER-ALS Phase 1/2 Trial of VTx-002, a First-in-Class Vectorized Antibody Targeting TDP-43 Pathology in ALS
December 3, 2025
·
1 min read
Press Releases
Leadership Transition at Vetter: Thomas Otto Retires
December 3, 2025
·
1 min read
Editorial
Pazdur’s Sudden Exit Leaves Just Three Veterans in FDA’s Senior Ranks
Nearly 90% of senior leaders who were at the FDA a year ago are no longer with the agency, a
BioSpace
analysis shows. None remain from the Office of the Commissioner.
December 3, 2025
·
4 min read
·
Jef Akst
Press Releases
Cell And Gene Therapy Clinical Trials Market Accelerates from USD 12.47 Billion in 2025 to USD 45.31 Billion by 2034
December 3, 2025
·
1 min read
Press Releases
U.S. Bispecific Antibody Market to Worth USD 448.62 Billion by 2035
December 3, 2025
·
1 min read
Press Releases
Drug Discovery Market Set to Reach USD 174.14 Billion by 2035 Driven by AI-Powered Innovation
December 3, 2025
·
1 min read
Press Releases
BioHarvest Sciences Announces Launch of VINIA Blood Flow Hydration Product
December 3, 2025
·
1 min read
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