PharmaWatch Challenge

European Medicines Agency Rejects Amgen and UCB’s Osteoporosis Medication Romosozumab

Jul 2, 2019 | Amgen, European Medicines Agency, Osteoporosis, PharmaWatch Challenge

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...

FDA Issues a Complete Response Letter to Daiichi Sankyo as Reason for Quizartinib NDA Rejection

Jun 23, 2019 | FDA Response, NDA, PharmaWatch Challenge, 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...

TRIALSITE NEWS IS THE ONLY DIGITAL MEDIA DEDICATED 100% TO TRANSPARENT AND OPEN COVERAGE OF CLINICAL RESEARCH TRIAL SITES AROUND THE GLOBE. BASED IN THE SILICON SLOPES IN DOWNTOWN SALT LAKE CITY, UTAH, WE ARE FOUNDED BY A TEAM OF EXPERTS IN THE CLINICAL TRIALS INDUSTRY AND DEDICATED TO TRANSPARENCY, QUALITY AND CLINICAL TRIAL INNOVATION.

159 WEST BROADWAY SUITE 200
SALT LAKE CITY, UT 84101

European Medicines Agency Rejects Amgen and UCB’s Osteoporosis Medication Romosozumab

FDA Issues a Complete Response Letter to Daiichi Sankyo as Reason for Quizartinib NDA Rejection

Pin It on Pinterest