The FDA simultaneously approved a companion diagnostic for use with BALVERSA, the QIAGEN therascreen ® FGFR RGQ Reverse-transcription (RT)-polymerase chain reaction (PCR) Kit, which is the first ...

In a confirmatory trial win for Johnson & Johnson's Balversa, which was approved in 2019 on an accelerated basis, the treatment outdid chemotherapy in certain bladder cancer patients. (JNJ) Johnson & ...

Targeted therapies that aim at specific genetic biomarkers have been widely adopted in several cancer types, but not in bladder cancer. But a new nod the FDA doled out Friday could change that—and ...

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 ...

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 ...

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) ...

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 ...

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 ...

Johnson & Johnson’s Balversa has become the first targeted therapy for bladder cancer after an FDA approval at the tail end of last week for patients with mutations in the FGFR gene. Balversa ...

RARITAN, N.J., Sept. 17, 2021 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from the Phase 1b/2 NORSE (NCT03473743) study evaluating BALVERSA ® ...

BEERSE, BELGIUM, Aug. 23, 2024 (GLOBE NEWSWIRE) -- Janssen-Cilag International NV, a Johnson & Johnson company, today announced that the European Commission (EC) has approved BALVERSA® (erdafitinib) ...

(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 ...