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 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 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...
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...
On 31 January 2022, the anticipated European Union (EU) Clinical Trials Regulation 536/2014 (EU-CTR) came into effect, replacing the long-standing European Union Clinical Trials Directive 2001/20/EC (EU-CTD) legislation that regulates the clinical trial landscape in...
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...
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