FDA grants orphan drug status to Anavex 2-73 to treat infantile spasms
It gives Anavex a seven year window of commercial exclusivity in the US in the area of infantile spasms, prioritized consultation by the FDA on clinical studies and
Kyowa Kirin subsidiary Kyowa Kirin EMEA has received approval from the European Commission (EC) to expand the use of Crysvita (burosumab) for treating X-linked hypophosphataemia (XLH) in infants aged one month to one year across the EU and European Economic Area.
The final agreement will be signed, inter alia, subject to the completion of an initial clinical trial in the technology to the satisfaction of Therapix, and the completion
Under the double-blind, double-dummy, parallel group FULFIL study, 1,810 patients were randomized to receive either GSK’s fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) or budesonide/formoterol. The study met its objectives, with the