Solid Biosciences Announces Positive Feedback From Type C Meeting With FDA for SGT-003 Gene Therapy for Duchenne Muscular Dystrophy (Globe Newswire)
Solid Biosciences Inc., which acquired UF startup AavantiBio, announced a positive regulatory update from its recent Type C meeting with the U.S. FDA that supports the continued advancement of SGT-003 as a potential treatment for Duchenne muscular dystrophy.
TuHURA Biosciences Received FDA Orphan Drug Designation for IFx-2.0 for the Treatment of Stage IIB To Stage IV Cutaneous Melanoma (TuHURA Biosciences)
TuHURA Biosciences, formed by CohBar and Morphogenesis, a UF startup, announced that the U.S FDA has granted Orphan Drug Designation (ODD) to IFx-2.0 for the treatment of stage IIB to stage IV cutaneous melanoma.
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 Granted FDA Fast Track Designation for GNSC-001 in Patients With Osteoarthritis (OA) of the Knee
UF Startup Genascence Corporation announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) for GNSC-001, a potential first-in-class gene therapy for the treatment of patients with osteoarthritis (OA) of the knee.
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 completed the rolling submission process for its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Avance Nerve Graft®.