Postmenopausal women with osteoporosis who received a regimen of three separate, 6-month cycles of daily teriparatide followed by one subcutaneous injection of denosumab experienced a moderate gain in ...
The U.S. Food and Drug Administration (FDA) approved the expanded indication of Prolia for the treatment of osteoporosis associated with newly initiating or sustained systemic glucocorticoid therapy ...
Amgen (NASDAQ:AMGN) today announced the U.S. Food and Drug Administration (FDA) approved a new indication for Prolia® (denosumab) as a treatment to increase bone mass in men with osteoporosis at high ...
THOUSAND OAKS, Calif., June 1 /PRNewswire-FirstCall/ -- Amgen Inc. (Nasdaq: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Prolia ...
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 ...
13d
mAbxience and Amneal Announces FDA Approval of Denosumab Biosimilars Referencing Prolia® and XGEVA®
Abxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, and Amneal Pharmaceuticals, Inc. ("Amneal" or the "Company") (NASDAQ: AMRX), today announced that the U.S.
JERSEY CITY, N.J., March 4, 2025 /PRNewswire/ -- Celltrion today announced that the U.S. Food and Drug Administration (FDA) has approved STOBOCLO ® (CT-P41, denosumab-bmwo) and OSENVELT ® (CT-P41, ...
TipRanks on MSN
Dr. Reddy’s faces FDA setback on AVT03 denosumab biosimilar after manufacturing inspection
Dr Reddy’s Laboratories ( ($RDY) ) just unveiled an update. On December 31, 2025, Dr. Reddy’s Laboratories disclosed that its wholly owned Swiss ...
INCHEON, Korea, February 15, 2025--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for ...
Celltrion has received permission from the Food and Drug Administration for Stoboclo (CT-P41, denosumab-bmwo) and Osenvelt (CT-P41, denosumab-bmwo), biosimilars referencing Prolia (denosumab) and ...
Approvals expand Amneal’s biosimilars portfolioCompany expects to commercialize six biosimilars across eight presentations by 2027BRIDGEWATER, ...
Results that may be inaccessible to you are currently showing.
Hide inaccessible results
Feedback