Researchers published the study covered in this summary on researchsquare.com as a preprint that has not yet been peer reviewed. Study participants had no clinical fractures during 24 months of follow ...

Subsequent denosumab doses were associated with lower risks for hypocalcemia among patients with osteoporosis and chronic kidney disease . Magnitude of serum calcium decrease is smaller with ...

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 ...

Findings showed treatment with Prolia significantly increased the risk of developing severe hypocalcemia compared with bisphosphonates, especially in patients with advanced CKD. In patients with ...

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 ...

FDA’s boxed warning on denosumab follows study results showing increased and early risks of severe hypocalcemia in patients on dialysis. The Food and Drug Administration (FDA) has added a new boxed ...

“In a hypothetical health plan covering 1 million lives, adding biosimilar denosumab to a health plan formulary may contribute to significant cost savings; savings can be reinvested to further expand ...

In another first, Sandoz launched in November 2025 the first FDA-approved biosimilar of Tysabri (natalizumab). Tyruko (natalizumab-sztn) is used to treat adult patients with relapsing multiple ...

Sandoz has obtained the Food and Drug Administration’s clearance for Wyost (denosumab-bbdz) and Jubbonti (denosumab-bbdz), the only FDA-approved denosumab biosimilars, to treat all indications of ...

Thousand Oaks biotech giant Amgen Inc. marked the new year with both some bad news and a positive development. On the unwelcome news front, on Jan. 19, the Food and Drug Administration announced it ...