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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
Press Releases
Junevity Expands Seed Funding to $20 Million for Cell Reprogramming with siRNA
December 3, 2025
·
3 min read
Press Releases
TRIANA Biomedicines Announces Oversubscribed $120M Series B Financing to Advance its Molecular Glue Degrader Pipeline
December 3, 2025
·
3 min read
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