Degevma (denosumab-adet) was approved by the FDA on September 25, 2026 for prevention of skeletal-related events in multiple myeloma and bone metastases from solid tumors; giant cell tumor of bone; hypercalcemia of malignancy refractory to bisphosphonate therapy (the Xgeva indications).
The FDA approved Degevma (denosumab-adet), Teva's biosimilar to Xgeva (denosumab), on September 25, 2026 (BLA 761481, section 351(k)); the letter licenses it as biosimilar to and interchangeable with Xgeva. Teva announced it on September 28, 2026.
The FDA's approval letter for BLA 761481 is dated September 25, 2026; the application was submitted under section 351(k) of the Public Health Service Act, the biosimilar pathway, and received September 29, 2025, and the letter licenses Degevma as biosimilar to and interchangeable with US-Xgeva (denosumab) 120 mg/1.7 mL (FDA approval letter). Per the letter, Degevma is indicated for prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, for giant cell tumor of bone in adults and skeletally mature adolescents that is unresectable or where surgical resection is likely to result in severe morbidity, and for hypercalcemia of malignancy refractory to bisphosphonate therapy. Teva announced the approval on September 28, 2026 (Teva release); with Ponlimsi, its Prolia biosimilar approved in March 2026, Teva says it now covers the indications of both denosumab reference products. pdufa.bio did not hold a goal date for this application, so no early or late margin is computed.
Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
Primary source: FDA approval letter, BLA 761481, September 25, 2026
FDA record of the action: the FDA approved on September 25, 2026, per BLA 761481 ORIG-1 (FDA letter). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
Yes. The FDA approved the application for Degevma (denosumab-adet) on September 25, 2026, per the FDA's own record. The primary source is linked on this page.
Degevma (denosumab-adet) is a Teva Pharmaceutical Industries (TEVA) program. The FDA decision came on September 25, 2026; the company's own announcement is linked on this page.
Measured over the 120 trading days before the decision (T-120 to T-1), TEVA moved +34.9%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.