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Amgen announced that the randomized, double-blind, placebo-controlled Phase 3 Aranesp® (darbepoetin alfa) ARCADE trial met its primary endpoint of reducing the incidence of red blood cell transfusions in anemic patients with low and intermediate-1 risk Myelodysplastic Syndrome (MDS) at the end of the blinded 25-week study period. Aranesp also significantly improved erythroid response, a key measure of the formation of new red blood cells. Detailed results will be submitted to a future medical conference and for publication.
Kindred Biosciences seeks US FDA approval for Zimeta to treat pyrexia in horseKindred Biosciences, Inc., announced the submission to FDA of the Effectiveness Technical Section of the New Animal Drug Application (NADA) for Zimeta™ (dipyrone injection, KIND-012).
Merck, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding Merck's Supplemental New Drug Applications for ZETIA® and VYTORIN® for the reduction of the risk of cardiovascular events (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina, or need for revascularization) in patients with coronary heart disease.
Wenzel Spine, Inc., a pioneer medical device company focused on providing minimally invasive, stand-alone alternatives to traditional spinal fusion, announced today that it received clearance from the U.S. Food and Drug Administration (FDA) to market VariLift®-LX as an interbody fusion device for stand-alone use in the lumbar spine.
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