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
Atsena Therapeutics Receives Rare Pediatric Disease Designation From the U.S. FDA for ATSN-201 Gene Therapy To Treat X-Linked Retinoschisis
UF startup Atsena Therapeutics, a clinical-stage gene therapy company focused on bringing the life-changing power of genetic medicine to reverse or prevent blindness, announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease designation (RPD) for ATSN-201 for the treatment of X-linked retinoschisis (XLRS).
Neobiosis Announces FDA Approval of IND for Use of ViXomeTM in COVID-19 ‘Post COVID Syndrome’
Neobiosis, A UF Accelerate resident client, is a leading research and manufacturing biotechnology company focused on pioneering the development of novel therapeutics from perinatal tissues as a new class of medicines. Today, Neobiosis announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for ViXome™, its drug for the treatment of 'Post COVID Syndrome (AKA "Long Haul COVID Syndrome").
Exactech Announces FDA Breakthrough Device Designation for JointMedica’s Polymotion® Hip Resurfacing System
UF Startup Exactech, a developer and producer of innovative implants, instrumentation, and smart technologies for joint replacement surgery, announced that the U.S. Food and Drug Administration (FDA) has granted a Breakthrough Device Designation for JointMedica’s Polymotion® Hip Resurfacing System.
Dialectic Therapeutics Announces DT2216 Has Received Orphan Drug Designation From the FDA for the Treatment of T-Cell Lymphoma
UF startup Dialectic Therapeutics, Inc. (Dialectic®), announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to DT2216 for the treatment of T-cell lymphoma.
Morphogenesis’ Skin Cancer Vaccine Gets FDA ‘Fast Track’
Tampa company Morphogenesis, a UF startup, has received a “fast track” designation for its skin cancer vaccination from the United States Food and Drug Administration.
UF Anticancer Drug Receives FDA Clearance for Clinical Trials
An anticancer drug developed by researchers from the University of Florida College of Pharmacy has become the first drug of its kind allowed to proceed to clinical trial by the U.S. Food and Drug Administration.
Dialectic Therapeutics Receives FDA Clearance of IND Application for for Its Lead Product Candidate To Treat Cancer
UF startup Dialectic Therapeutics, Inc., a Texas-based biotechnology company focused on creating innovative new technologies to treat cancer, announced that the U.S. Food and Drug Administration (FDA) has concluded that Dialectic may proceed with its clinical investigation for its lead product candidate, DT2216, a unique compound built using its proprietary and novel Antiapoptotic Protein Targeted Degradation (APTaD) technology.
