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 ...
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 ...
Approvals expand Amneal’s biosimilars portfolioCompany expects to commercialize six biosimilars across eight presentations by 2027BRIDGEWATER, ...
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 ...
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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