Top Regulatory News Stories – Week Ending September 14, 2018

The US FDA approved AstraZenea’s Lumoxiti (moxetumomab pasudotox-tdfk) for certain patients with relapsed or refractory hairy cell leukemia.  https://www.astrazeneca.com/media-centre/press-releases/2018/us-fda-approves-lumoxiti-moxetumomab-pasudotox-tdfk-for-certain-patients-with-relapsed-or-refractory-hairy-cell-leukaemia.html   Amryt announced that the FDA has granted IND clearance for AP101. This enables the Company to begin opening US clinical trial sites as part of its ongoing global EASE Phase III clinical trial in Epidermolysis[…]