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FDA approves Pfizers Daurismo to be used with low-dose cytarabine to treat some new cases of acute myeloid leukemia.[ Price : $8.95]
A CDRH report says there is improved medical device manufacturer compliance as a result of increased inspection oversight using a ...[ Price : $8.95]
Mylan says it is addressing an FDA Warning Letter about its Morgantown, WV, drug manufacturing plant in the context of a comprehen...[ Price : $8.95]
Some stakeholders fault FDA for issuing a draft guidance on product identifiers under the Drug Supply Chain Security Act just mont...[ Price : $8.95]
Federal Register notice: FDA submits to OMB an information collection extension entitled Requirements on Content and Format of Lab...[ Price : $8.95]
FDA accepts for priority review a Daiichi Sankyo NDA for quizartinib for treating adult patients with relapsed/refractory FLT3-ITD...[ Price : $8.95]
FDA says Mylan has recalled 15 lots of valsartan-containing drugs that tested positive for NDEA above acceptable levels.[ Price : $8.95]
FDA grants OBI Pharma an Orphan Drug Designation for OBI-888 for treating pancreatic cancer.