Managed Healthcare Executive10h
FDA Approves Two More Denosumab Biosimilars, Conexxence and Bomyntra
The fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, ...
Zacks Investment Research on MSN8d
FDA Accepts RDY & ALVO's Prolia & Xgeva Biosimilar BLA for Review
Dr. Reddy’s Laboratories RDY and partner, Alvotech ALVO, announced the FDA’s acceptance of a regulatory filing, seeking the ...
Drug Store News6d
FDA accepts BLA submission from Dr. Reddy's, Alvotech for proposed Prolia, Xgeva biosimilars
After approval by the FDA, AVT03 is expected to be supplied in a single-dose prefilled syringe containing 60 mg in a 1 ml ...
The American Journal of Managed Care24d
FDA Approves Denosumab Biosimilars Stoboclo and Osenvelt
Osenvelt is a receptor activator of NF-κb ligand inhibitor referencing Xgeva. The FDA approved the drug as a 120 mg/1.7 mL injection that is indicated to prevent skeletal-related events in ...
TipRanks on MSN9d
Dr. Reddy’s, Alvotech announce FDA acceptance of BLA for AVT03
Dr. Reddy’s Laboratories (RDY) and Alvotech (ALVO) announced that the U.S. Food and Drug Administration, FDA, has accepted a 351(k) Biologic ...
Yahoo Finance8d
FDA Accepts RDY & ALVO's Prolia & Xgeva Biosimilar BLA for Review
AMGN’s Xgeva helps prevent fractures, spinal cord compression and the need for bone-related surgery or radiation in patients with multiple myeloma or bone metastases from solid tumors.
Dr. Reddy’s, Alvotech announce FDA acceptance of AVT03 BLA
Dr. Reddy’s (RDY) and Alvotech (ALVO) announced that the FDA has accepted a 351(k) biologic license application submission for AVT03, developed ...