Aromatase inhibitors (AIs) are a cornerstone of adjuvant therapy for hormone receptor–positive breast cancer, significantly reducing recurrence and mortality. However, by suppressing estrogen ...
Teva shared that the Food and Drug Administration has accepted, and the European Medicines Agency has validated, applications for TVB-009P, a biosimilar candidate to Amgen’s Prolia (denosumab). Both ...
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 ...
Treatment strategies after denosumab discontinuation in non-metastatic breast cancer treated with AI
This narrative review by an expert International Osteoporosis Foundation (IOF) Working Group highlights an under-recognized bone health risk in women with early-stage, hormone receptor–positive breast ...
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 mAbxience ...
--Amgen today announced new data from a real-world study of nearly half of a million postmenopausal women with osteoporosis in the U.S. medicare program showing Prolia ® injection reduced fracture ...
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 ...
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