Teva wins FDA approval for DEGEVMA biosimilar across all Xgeva indications
FDA approves Teva’s DEGEVMA as an Xgeva biosimilar across oncology bone-disease indications, expanding its U.S. denosumab portfolio.
FDA approves Teva’s DEGEVMA as an Xgeva biosimilar across oncology bone-disease indications, expanding its U.S. denosumab portfolio.
Bristol Myers Squibb and Ono Pharmaceutical are suing Amgen over seven patents tied to its proposed Opdivo biosimilar ABP 206, opening an important legal battle around a cancer drug that generated more than $10 billion in 2025.
The FDA has reduced monitoring requirements around the first two Imdelltra doses, lowering an important logistical burden days after Amgen reported positive Phase 3 survival data in first-line extensive-stage small cell lung cancer.
GSK’s licensed B7-H3 antibody-drug conjugate Ris-Rez delivered median survival of 18.5 months versus 10.3 months with topotecan in a Chinese Phase 3 study, strengthening the company’s case for global development.
Amgen’s Phase 3 DeLLphi-305 trial met its primary overall survival endpoint with Imdelltra plus Imfinzi as first-line maintenance in extensive-stage small cell lung cancer.
A prespecified VESALIUS-CV analysis found a 20% reduction in mortality with Amgen’s Repatha among more than 12,000 high-risk adults without a previous heart attack or stroke, strengthening the case for intensive LDL lowering before the first major cardiovascular event.
Amgen and AstraZeneca say TEZSPIRE achieved both co-primary and all key secondary endpoints in the Phase 3 CROSSING study, potentially extending the TSLP-blocking biologic into eosinophilic esophagitis.
Amgen’s Tepezza is facing a broader thyroid eye disease treatment landscape after Viridian Therapeutics’ Lumvoa became another approved option, shifting attention toward how physicians may weigh evidence, safety, treatment burden and patient fit. Dr. Raymond Douglas, MD, PhD, who served as principal investigator in the international Tepezza trials that supported its United States Food and
Accord BioPharma launches Osvyrti and Jubereq as interchangeable denosumab biosimilars, testing price, payer access and provider adoption.
See how Lumvoa’s FDA approval could reshape thyroid eye disease treatment, challenge Tepezza and test Viridian’s launch strategy.