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Amgen Osteoporosis Drug Prolia Is Hit With FDA's Strictest Warning

The FDA said Amgen’s Prolia may lead to low levels of calcium, or hypocalcemia. The osteoporosis drug’s black box warning follows an FDA review of Centers for Medicare & Medicaid Services studies that found Prolia led to a significant increase in the risk of severe hypocalcemia compared to treatment with an older class of medicines. ....

Bio Zynteglo , Eli Lilly Forteo , Radius Health , Centers For Medicare Medicaid Services , European Commission , Vertex Pharmaceuticals , Risk Evaluation , Mitigation Strategy , Medicaid Services , Event Report System , Eli Lilly , Bluebird Bio , Satsuma Pharmaceutical , Shin Nippon Biomedical Laboratories , Weight Loss , Medical Devices , Healthcare Innovation , Medcity News , Medcity News , San Francisco , Life Sciences , Rock Health , Startup Advice , Startup Funding , Patient Monitoring System , Otion Sensors ,

FDA Approves Gene Therapy for Inherited Blood Disorder

FDA Approves Gene Therapy for Inherited Blood Disorder
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United States , Reshma Kewalramani , Bio Zynteglo , Drug Administration , Vertex Pharmaceuticals , Medicine Advanced , Effects Listedcasgevy , Bluebird Bio , Boston Children ,

World's most expensive drug approved at $5m a dose

CSL Behring’s haemophilia B gene therapy, a one-off infusion that frees patients from regular treatments, costs $US3.5 million ($5.2 million) a dose, making it the most expensive medicine in the world. ....

Novartis Zolgensma , Peter Marks , Bio Zynteglo , Behring Hemgenix , Brad Loncar , Drug Administration Center , Bluebird Bio , Drug Administration , Biologics Evaluation ,