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An FDA proposal to only allow stool for fecal matter transplants (FMT) from donors known to patients or their physicians has come under heavy fire from critics who argue it will actually make the procedure more risky and shut down stool banks. Read More
GlaxoSmithKline has withdrawn a marketing application for a cancer drug combination in Europe, saying it will wait for results from two ongoing Phase III trials before resubmitting the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