The UK's National Institute for Health and Care Excellence (NICE) has said it is minded not to recommend approval of CSL Behring and uniQure's Hemgenix gene therapy for ha
CSL and uniQure’s gene therapy for haemophilia B has been approved by the European Commission, ushering in a new era of therapy for patients with the bleeding disorder in
CSL's gene therapy for haemophilia B has been recommended for approval by the EMA's human medicine committee, setting up a decision by the European Commission early next year.
uniQure and CSL have become the first pharma companies to get regulatory approval for a gene therapy for haemophilia B anywhere in the world, after the FDA cleared their Hemgenix therapy fo
Dutch biotech uniQure and partner CSL Behring are planning to file for approval of their gene therapy for haemophilia B, armed with new trial data that they say answers earlier concerns abo
Bavarian Nordic is preparing to file for regulatory approval of a vaccine against chikungunya virus after its CHIKV VLP candidate showed protective efficacy in a second ph
To improve trial recruitment, engagement, and retention, and to increase the likelihood that trials reflect what matters most to patients, regulatory authorities increasingly point to metho