Amplia Therapeutics Limited (ASX: ATX) has announced that its Focal Adhesion Kinase (FAK) inhibitor, narmafotinib, has been granted Fast Track Designation by the United States Food and Drug Administration (FDA). This designation, aimed at expediting the development of drugs intended to address unmet medical needs in serious conditions, could provide an advantage in treating advanced […]
Shares of Longboard Pharmaceuticals, Inc. surged on Thursday after the United States Food and Drug Administration (FDA) granted both Rare Pediatric Disease designation and Orphan Drug designation to its investigational drug, bexicaserin, for the treatment of Dravet syndrome. Pre-market trading saw shares rise by 4.2%, reaching $30.53, a continuation of the company’s upward trend over […]
The European Commission (EC) has granted marketing authorisation for AKANTIOR (polihexanide), the first and only approved treatment for acanthamoeba keratitis (AK) globally, announced Avanzanite Bioscience B.V., a commercial-stage specialty pharmaceutical company. The approval, which applies to both adults and children aged 12 and over, marks a significant milestone for the treatment of this rare and […]