Japan’s decision gives quizartinib its first approval globally in specific first-line AML indication, in relatively small but high-need patient population.

CMS said Medicare will cover anti-amyloid antibodies for early Alzheimer’s disease upon traditional approval from the US FDA if prescribed by doctors participating in a patient registry. 

Blood-collection technology firm Tasso has been recommended for certification by MDSAP. The international qualification is part of a push to offer the company’s technology in countries such as Australia and Canada, CEO Ben Casavant told Medtech Insight. 

AstraZeneca had hoped data from Phase III PROpel would lead to an all-comers indication in first-line, metastatic castration-resistant prostate cancer, but new indication is limited to BRCA mutations.