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 ...
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 ...
Approvals expand Amneal’s biosimilars portfolioCompany expects to commercialize six biosimilars across eight presentations by 2027BRIDGEWATER, ...
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 ...
Following the positive opinions of the Committee for Medicinal Products for Human Use (CHMP), the European Commission has granted marketing authorizations for Teva’s biosimilars PONLIMSI and DEGEVMA ...
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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 ...
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