NeXtGen Biologics Successfully Completes First FDA Audit With Zero 483 Observations (Globe Newswire)
UF Innovate | Accelerate resident client NeXtGen Biologics announced the successful completion of a two-day inspection by the U.S. Food and Drug Administration (FDA).
Myosin Therapeutics Receives FDA Fast Track Designation for MT-125 in Glioblastoma (PR Newswire)
UF startup Myosin Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to MT-125 for the treatment of glioblastoma (GBM).
Solid Biosciences Receives FDA Fast Track Designation for SGT-501 First-in-Class Gene Therapy for Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Solid Biosciences Inc., which acquired UF startup AavantiBio, announced that it received Fast Track designation from the U.S. Food and Drug Administration (FDA) for SGT-501, the Company’s novel, AAV-based investigational gene therapy for the treatment of catecholaminergic polymorphic ventricular tachycardia (CPVT).
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)
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).
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.
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).