City of Hope®, one of the largest and most advanced cancer research and treatment organizations in the United States and a ...

Dr. Reddy’s Laboratories RDY and partner, Alvotech ALVO, announced the FDA’s acceptance of a regulatory filing, seeking the ...

The likelihood of achieving target T-scores at the total hip and lumbar spine with denosumab depends on baseline BMD in postmenopausal women with osteoporosis.

City of Hope®, one of the largest and most advanced cancer research and treatment organizations in the United States and a top research center for diabetes and other life-threatening illnesses, is ...

The approval was based on a comprehensive clinical data package, which included a single phase 1 trial and a phase 3 trial.

HYDERABAD, India & REYKJAVIK, Iceland I March 18, 2025 I Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; along with ...

The FDA has approved two new biosimilars of denosumab for all indications of the reference medications Prolia and Xgeva, ...

Celltrion Inc. is on a biosimilar roll with the U.S. FDA this month, having gained clearance of Stoboclo and Osenvelt as products referencing Amgen Inc.’s biologic, denosumab (Prolia, Xgeva), along ...

The biosimilar approval was based on a comprehensive clinical data package, which included a double-blind, randomized, active-controlled phase 3 trial (ClinicalTrials.gov Identifier: NCT04757376) that ...

Clinical studies confirmed equivalent efficacy, safety, and pharmacokinetics between denosumab biosimilars and reference products. Common adverse events for Ospomyv include back pain and ...

The FDA has accepted Amneal’s biologics licensing application for two biosimilars referencing Prolia and Xgeva.

Amneal announced FDA acceptance of its Biologics License Application (BLA) for two proposed denosumab biosimilars ...