Prolia is a monoclonal antibody that binds to a specific protein on osteoclasts and decreases their activity. Osteoclasts are responsible for dissolving and breaking down old or damaged bone cells. By ...
Both applications, a Biologics License Application (BLA) in the U.S., seeking interchangeability, and a Marketing Authorization Application (MAA) in the European Union (EU), include all indications ...
Richter and Hikma have received the green light from the Food and Drug Administration for their biosimilar denosumab products, Enoby (denosumab-qbde) and Xtrenbo (denosumab-qbde), referencing Prolia ...
As Sandoz gears up to launch one of the most anticipated biosimilars of the year, the company could face near-term competition thanks to a new agreement between Amgen and Celltrion. Late last week, ...
Shanghai Henlius Biotech and Organon have received permission from the Food and Drug Administration for Bildyos (denosumab-nxxp) injection 60 mg/ml and Bilprevda (denosumab-nxxp) injection 120 mg/1.7 ...
Dr. Reddy’s Laboratories RDY and partner, Alvotech ALVO, announced the FDA’s acceptance of a regulatory filing, seeking the approval of AVT03, a proposed biosimilar of Amgen’s AMGN Prolia (denosumab) ...
BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global biopharmaceutical company, and ...
Original Medicare (Part A and Part B), Part D, and Medicare Advantage typically offer coverage for the osteoporosis drug Prolia. However, individuals must meet certain requirements for Part B coverage ...
On October 8, 2024, Teva Pharmaceutical Industries Ltd. announced that the United States Food and Drug Administration (FDA) has accepted, and the European Medicines Agency (EMA) has validated, ...
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