Teva shared that the Food and Drug Administration has accepted, and the European Medicines Agency has validated, applications for TVB-009P, a biosimilar candidate to Amgen’s Prolia (denosumab). Both ...
According to a long-term safety study and a separate FDA internal study, Prolia had an increased risk of hypocalcemia in patients with advanced kidney disease on dialysis. Patients with advanced ...
Please provide your email address to receive an email when new articles are posted on . The FDA is investigating the risk of severe hypocalcemia in patients on dialysis treated with the osteoporosis ...
The FDA has added a serious warning to the prescribing information for Amgen Inc’s (NASDAQ:AMGN) drug Prolia (denosumab), emphasizing an increased risk of severely low calcium levels in specific ...
Generic drugmaker Sandoz (OTCQX:SDZNY) announced Tuesday that the FDA had approved two of its biosimilar products targeting Amgen’s (AMGN) blockbuster bone therapies, Prolia and Xgeva, collectively ...
SHANGHAI, China & JERSEY CITY, N.J.--(BUSINESS WIRE)--Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the US Food and Drug Administration (FDA) has accepted the ...
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