Johnson & Johnson’s Janssen subsidiary has submitted a Type II variation application to the European Medicines Agency (EMA) seeking approval of a new indication 10 October 2023
Leading regulatory bodies around the world have various pathways in place to speed up the approval process for promising medicines that offer a solution to unme 6 October 2023
Addressing what has been dubbed the ‘triple A’ challenge of access, affordability and availability has been an objective of the European Medicines Agency (EMA) 29 September 2023
The European Commission (EC) has granted conditional marketing authorization for Tepkinly (epcoritamab) as a monotherapy to treat adults with relapsed or refrac 25 September 2023
Italian drugmaker Menarini has secured European approval for Orserdu (elacestrant) as a monotherapy for the treatment of certain people with advanced or metasta 21 September 2023
The European Commission (EC) has approved Otsuka Pharmaceutical and Astex Pharmaceuticals’ Inaqovi (oral decitabine and cedazuridine) as monotherapy for the tre 19 September 2023
A commercial stage biopharmaceutical R&D company, focused on the development of products that address the medical challenges in the therapeutic area of anti-infectives.