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MALVERN, PA — Ocugen Inc. (Nasdaq: OCGN) has completed enrollment and dosing in its Phase 2/3 clinical trial evaluating a gene therapy candidate for Stargardt disease.
Ocugen Completes Dosing in Stargardt Disease Gene Therapy Trial Read More
WASHINGTON, D.C. — Children with a life-threatening immune disorder now have a new treatment option following federal approval of the first gene therapy designed to correct the underlying cause of …
FDA Approves First Gene Therapy for Rare Childhood Immune Disorder Read More MALVERN, PA — Ocugen, Inc. (Nasdaq: OCGN) announced it has completed enrollment for the Phase 3 liMeliGhT clinical trial evaluating OCU400, a gene therapy candidate for retinitis pigmentosa, a group …
Ocugen Completes Enrollment for Phase 3 Trial of OCU400 Gene Therapy Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration signaled a sweeping shift in how cutting-edge therapies reach patients this month, unveiling regulatory flexibility for cell and gene therapies, modernizing …
FDA Clears Faster Path for Gene Cures as Rare Disease Breakthrough Arrives Read More
WASHINGTON, D.C. — The Food and Drug Administration rolled out a rapid-fire series of moves this month that could reshape how Americans manage chronic disease, treat rare and life-threatening blood …
FDA’s Week of Breakthroughs: New Gene Therapy, New Antibiotics, New Rules Read More
WASHINGTON, D.C. — The long-standing FDA warnings on hormone replacement therapy for menopause are being dismantled, as the U.S. Department of Health and Human Services on Monday announced the removal …
HHS Overhauls Menopause Drug Warnings as FDA Unveils Major Women’s Health Shift Read More
WAYNE, PA & UTRECHT, Netherlands — NanoCell Therapeutics, Inc. announced the appointment of Prof. Zoltán Ivics, PhD, Jens Hasskarl, MD, PhD, and Jake Brenner, MD, PhD, to its Scientific Advisory …
NanoCell Therapeutics Expands Scientific Advisory Board With Global Experts in Gene Therapy and Clinical Development Read More MALVERN, PA — Ocugen, Inc. (NASDAQ: OCGN) has received a key regulatory boost in its bid to bring a gene therapy for Stargardt disease to market, with the European Medicines …
Ocugen Gains EMA Backing for Single Pivotal Trial to Support Stargardt Disease Gene Therapy Approval Read More WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has recommended lifting the voluntary clinical hold on Elevidys for ambulatory patients with Duchenne Muscular Dystrophy (DMD), following a thorough …
FDA Clears Path for Resumed Use of Elevidys Gene Therapy in Ambulatory DMD Patients Read More
BERWYN, PA — Specialty pharmacy and healthcare services firm AscellaHealth is spotlighting its role as the HUB partner for Abeona Therapeutics (Nasdaq: ABEO) in the launch and commercialization of ZEVASKYN™, …
AscellaHealth Drives Patient-Centric Launch Support for Groundbreaking Gene Therapy ZEVASKYN Read More