FDA delays approval on JAK inhibitor


The FDA has delayed approving the oral JAK inhibitor baricitinib, saying it needs more clinical data. The U.S. drug regulator issued manufacturers Incyte and Eli Lilly with a Complete Response Letter stating it needed more information in order to be sure of the correct dosing and to “further characterize safety concerns across treatment arms”. The ...


Already a member? Login to keep reading


OR
© 2017 the limbic