Amgen and UCB’s osteoporosis drug romosozumab was rejected by the European Medicines Agency (EMA) due to the potential for cardiovascular risks. EMA declared that they found some evidence that the drug known as Evenity increases the probability of myocardial...
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FDA Issues a Complete Response Letter to Daiichi Sankyo as Reason for Quizartinib NDA Rejection
The FDA provided a complete response letter to Daiichi Sankyo, alerting them as to the reasons why the new drug application (NDA) for quizartinib as a treatment of adult adults with relapsed/refractory FLT3-ITD—positive acute myeloid leukemia (AML) would not be...