Friday afternoon, the FDA approved Johnson & Johnson’s (NYSE:JNJ) supplemental New Drug Application (sNDA) for Balversa (erdafitinib) for adult patients with locally advanced or metastatic urothelial ...

When the FDA converts an accelerated approval into a full nod, it’s typically associated with a wider label for the drug at hand. But in the case of Johnson & Johnson’s Balversa, the FDA narrowed the ...

Some patients with metastatic bladder cancer and FGFR3 genetic alterations may benefit from Balversa, as it “represents a critical need,” an expert said. The recent approval of Balversa (erdafitinib) ...

New York, USA, March 04, 2025 (GLOBE NEWSWIRE) -- BALVERSA Adoption on the Rise: Meeting Unmet Needs in Advanced Urothelial Cancer | DelveInsight DelveInsight's "BALVERSA Market Size, Forecast, and ...

Johnson & Johnson’s Balversa can keep some metastatic bladder cancer patients alive longer than chemotherapy, according to a study of 266 who have fibroblast growth factor receptor (FGFR) gene ...

DUBLIN--(BUSINESS WIRE)--The "Balversa - Drug Insight, 2019" report has been added to ResearchAndMarkets.com's offering. Balversa - Drug Insight, 2019 report provides comprehensive information of the ...

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Balversa has been submitted to the FDA for approval to treat patients with locally advanced or metastatic urothelial carcinoma. A supplemental New Drug Application (sNDA) has been submitted to the U.S ...

Balversa (erdafitinib) marks the first and only bladder cancer therapy to target FGFR3 alterations, with a demonstrated increase in overall survival from 7.8 months to 12.1 months. On Nov. 6, 2024, ...

Johnson & Johnson JNJ announced that the European Commission has granted marketing approval to its drug Balversa (erdafitinib) for treating unresectable or metastatic urothelial carcinoma (UC), ...

Johnson & Johnson (J&J) has announced that its pan-FGFR tyrosine kinase inhibitor Balversa (erdafitinib) has been granted marketing authorisation by the Medicines and Healthcare products Regulatory ...

(RTTNews) - Janssen-Cilag International NV, a subsidiary of Johnson & Johnson (JNJ), announced on Friday that the European Commission has approved Balversa or Erdafitinib, as a once-daily oral ...