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GlaxoSmithKline has withdrawn a marketing application for a cancer drug combination in Europe, saying it will wait for results from two ongoing Phase III trials before resubmitting the application. Read More
Unlike in the EU, Swiss regulators will not accept marketing authorization applications for biosimilars of low-molecular-weight heparin products already approved in Switzerland. Read More
Global drug giant Pfizer said Tuesday that its Phase III Profile 1014 postmarketing commitment study of anaplastic lymphoma kinase-inhibitor Xalkori met its primary objective of prolonging progression-free survival in previously untreated patients with ALK-positive advanced non-squamous non-small cell lung cancer (NSCLC) compared with platinum-based chemotherapy. Read More
Japanese regulators have approved Otsuka Pharmaceutical’s Samsca to treat autosomal dominant polycystic kidney disease, or ADPKD — an expanded indication that the FDA rejected last year. Read More
EU drug regulators Friday recommended Endocyte’s vintafolide for approval as an ovarian cancer treatment, providing the drugmaker with a major milestone in its attempt to market its first product. Read More
Forest Laboratories and Gedeon Richter on Friday touted positive topline results from a mid-stage trial of their investigational antipsychotic cariprazine to treat major depressive disorder (MDD), renewing hope for the candidate recently rejected by the FDA in another indication. Read More