Benzinga.com

Amgen's Blockbuster Osteoporosis Drug Prolia Flagged With FDA Strictest Warning

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 ...

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 ...
Healio

FDA approves two new biosimilars of denosumab

Please provide your email address to receive an email when new articles are posted on . Samsung Bioepis received approval for two biosimilars of denosumab that are interchangeable with Prolia and ...
The American Journal of Managed Care

FDA Approves First 2 Denosumab Biosimilars

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 ...
Healio

Two new denosumab biosimilars earn FDA approval

Please provide your email address to receive an email when new articles are posted on . The FDA approved denosumab-bmwo for all indications of the reference drugs Prolia and Xgeva. According to a ...
Business Wire

US FDA Accepts Biologics License Application (BLA) for HLX14, Biosimilar Candidate of PROLIA/XGEVA (denosumab)

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 ...

Amneal Announces FDA Approval of Denosumab Biosimilars Referencing Prolia® and XGEVA®

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