Genascence Announces U.S. Food and Drug Administration Grants Regenerative Medicine Advanced Therapy Designation to GNSC-001 for Knee Osteoarthritis (OA)
UF startup Genascence Corporation announced that the U.S. FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to GNSC-001, a potential first-in-class gene therapy that targets interleukin-1 (IL-1) for the treatment of knee osteoarthritis (OA)
Solid Biosciences Announces FDA IND and Health Canada CTA Approval for First-in-Class Cardiac Gene Therapy To Treat Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Solid Biosciences, which acquired UF startup AavantiBio, announced FDA and Health Canada approval to begin clinical trials of SGT-501, a gene therapy targeting CPVT, a severe heart rhythm disorder caused by RYR2 mutations.
Atsena Therapeutics Announces Alignment With FDA on Regulatory Pathway to Approval for ATSN-201 in X-Linked Retinoschisis (XLRS)
UF startup Atsena Therapeutics received FDA approval to expand its Phase 1/2 LIGHTHOUSE study of ATSN-201 into a pivotal Phase 1/2/3 trial to support a BLA submission for treating X-linked retinoschisis (XLRS).
Myosin Therapeutics Receives FDA Clearance To Initiate First-in-Human Trial of MT-125 in Glioblastoma
UF startup Myosin Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the company's Investigational New Drug (IND) application for MT-125.
Atsena Therapeutics Granted U.S. FDA Fast Track Designation for ATSN-201 Gene Therapy To Treat X-Linked Retinoschisis
UF startup Atsena Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ATSN-201 for the treatment of X-linked retinoschisis (XLRS).
Myosin Therapeutics Closes Second Seed Round To Advance Clinical Trials for Innovative Cancer and Neuroscience Therapies
UF startup Myosin Therapeutics, Inc., a biotechnology company developing novel therapies for cancer and neurological disorders, has closed its second seed funding round, raising over $3 million to supplement significant investment from the National Institutes of Health.
Solid Biosciences Receives FDA Fast Track Designation for SGT-212 Dual Route of Administration Gene Therapy for Friedreich’s Ataxia
Solid Biosciences Inc., a life sciences company that acquired UF startup AavantiBio, announced that it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for SGT-212, the Company’s, AAV-based gene therapy candidate for the treatment of Friedreich’s ataxia (FA).
Rise Therapeutics Receives FDA IND Clearance To Initiate Clinical Testing of R-5780 in Cancer
UF startup Rise Therapeutics announced that the U.S. FDA has accepted its investigational new drug (IND) application to proceed with a cancer Phase 1 clinical trial for its program candidate, R-5780.
Solid Biosciences Announces FDA IND Clearance for First-in-Industry Dual Route of Administration Gene Therapy To Treat Both Neurologic and Cardiac Manifestations of Friedreich’s Ataxia
Solid Biosciences Inc., a biotechnology company that acquired UF startup AavantiBio, announced that the U.S. FDA has cleared its Investigational New Drug application for SGT-212 for the treatment of Friedreich’s ataxia.
Axogen Completes Submission of Biologics License Application to U.S. Food and Drug Administration for Avance Nerve Graft®
UF startup Axogen, Inc., a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, announced that it has... Read More
