"Regulatory flexibility must be tailored for cell and gene therapies," commented FDA Commissioner Marty Makary. "These are ...
Clinical Trials Arena on MSN
FDA increases manufacturing flexibility for cell and gene therapies
Clinical and commercial quality controls are eased as the FDA looks to expedite therapy approvals in areas of unmet need.
Ori Biotech has lassoed a significant milestone for its space- and cost-efficient cell and gene therapy manufacturing platform. The FDA has granted the company’s IRO platform an Advanced Manufacturing ...
Belief Biomed Congratulates Partner Askbio On IND Acceptance By FDA For Investigational Gene Therapy For Late-Onset Pompe Disease. SHANGHAI, Jan. 14, 2026 /PRNewswire/ -- AskBio Inc. (AskBio), a gene ...
Researchers in the lab of Hans-Peter Kiem, MD, PhD, at Fred Hutch Cancer Center have devised a method that could one day treat genetic hematologic disorders by correcting how the body makes blood ...
AB-1009 program advances to Phase 1/Phase 2; clinical trial initiated in the United StatesTherapy granted United States Food ...
Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing ...
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What is cell & gene therapy AI
Cell and gene therapy are revolutionary approaches to treating diseases at the molecular level. They involve the manipulation ...
Forbes contributors publish independent expert analyses and insights. Bruce Japsen writes about healthcare business and policy. More than 70% of employers and health plans expect affordability of gene ...
A retired HGV driver was the first person in the world to take part in a clinical trial to extend the lifespan of blood ...
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