LEXEO Therapeutics: IND Clearance for LX2006 AAV-based Gene Therapy
The US Food and Drug Administration (FDA) has cleared LEXEO Therapeutics’ Investigational New Drug (IND) application for LX2006, an adeno-associated virus (AAV)-based gene therapy candidate to treat Friedreich’s ataxia cardiomyopathy (FA cardiomyopathy). FA...
Tandem Diabetes Care: FDA Clearance for Insulin Pump Using Mobile App
Tandem Diabetes Care today announced a US Food and Drug Administration (FDA) clearance of a bolus insulin dosing feature on the t:slim X2 insulin pump using the t:connect mobile app. This case is the first-ever FDA-cleared smartphone application capable of initiating...
AffaMed: IND Clearance for AM712 to Treat Retinal Diseases
AffaMed Therapeutics’ Investigational New Drug (IND) application for the clinical development of AM712 (ASKG712), a novel proprietary bispecific biologic molecule, has been cleared by the US Food and Drug Administration (FDA). AM712 has been designed to treat retinal...
Axcella: FDA Fast Track for AXA1125 to Treat NASH
The US Food and Drug Administration (FDA) has granted a Fast Track Designation to Axcella Therapeutics’ AXA1125 to treat non-alcoholic steatohepatitis (NASH) with liver fibrosis. NASH is the most severe form of fatty liver disease and if left untreated, can lead to...
FDA Awards QIDP Designation to Evofem Biosciences
The U.S. Food and Drug Administration (FDA) has awarded Evofem Biosciences a Qualified Infectious Disease Product (QIDP) Designation to EVO100 (Phexxi) for the prevention of chlamydia. Chlamydia has been reported to be responsible for up to half of all pelvic...
VCN Biosciences’ VCN-01 Receives FDA Designation
Synthetic Biologics has announced that VCN Biosciences has received an Orphan Drug Designation from the US Food and Drug Administration (FDA) for their therapy, VCN-01, to treat retinoblastoma. Retinoblastoma is a rare cancer of the eye that develops from immature...
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