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 ...
Amneal Pharma receives US FDA approval for denosumab biosimilars Prolia and Xgeva: Bridgewater, New Jersey Friday, December 26, 2025, 16:00 Hrs [IST] Bridgewater headquartered Amn ...
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Mabxience And Amneal Announces FDA Approval Of Denosumab Biosimilars Referencing Prolia® And XGEVA®
Mabxience And Amneal Announces FDA Approval Of Denosumab Biosimilars Referencing Prolia® And XGEVA®. mAbxience / Key word(s): Miscellaneous mAbxience and Amneal Announces FDA Approval of Denosumab ...
The US Food and Drug Administration (FDA) issued an alert today that cited preliminary evidence for a "substantial risk" for severe and symptomatic hypocalcemia and serious outcomes related to ...
Wyost and Jubbonti were approved as interchangeable biosimilars for Xgeva and Prolia; however, there is no launch date yet pending litigation with the maker of the reference products. Wyost and ...
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 ...
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