irblog.prnewswire.com

BALVERSA™ (erdafitinib) Receives U.S. FDA Approval for the Treatment of Patients with Locally Advanced or Metastatic Urothelial Carcinoma with Certain FGFR Genetic Alterations

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 ...
FiercePharma

ASCO: Johnson & Johnson's Balversa tops chemotherapy in bladder cancer trial

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 & ...
FiercePharma

J&J's Balversa gets mixed approval in bladder cancer as FDA ratchets up scrutiny on subgroup data, patient survival

The FDA full approval allows patients who’ve progressed on standard PD-1 treatment to get J&J's Balversa. (JNJ) When the FDA converts an accelerated approval into a full nod, it’s typically associated ...
Yahoo Finance

BALVERSA Adoption on the Rise: Meeting Unmet Needs in Advanced Urothelial Cancer | DelveInsight

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 ...
Benzinga.com

Johnson & Johnson Secures Complete FDA Approval For Bladder Cancer Drug Balversa, After Almost Five Years Of Accelerated Approval

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 ...
Cure Today

Balversa Fills a ‘Critical Need’ for Metastatic Bladder Cancer

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) ...
Cure Today

Janssen Seeks Approval for Balversa to Patients With Bladder Cancer

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 ...
Business Wire

Balversa Drug Insight Report, 2019: Drug Overview, Mechanism of Action, Clinical Trials, Regulatory Milestones, Deals, Partnerships, and Sales Forecasting to 2021 ...

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 ...
pharmaphorum

J&J gets US okay for first targeted bladder cancer drug

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 ...
Yahoo Finance

European Commission approves BALVERSA® (erdafitinib) for adult patients with unresectable or metastatic urothelial carcinoma

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) ...
Business Insider

Janssen Presents Results from Phase 1b/2 NORSE Study in Patients with Metastatic or Locally Advanced Urothelial Carcinoma Treated with BALVERSA® (erdafitinib) in Combination ...

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 ® ...
Nasdaq

Janssen-Cilag's Balversa Gets EC Approval For Metastatic Urothelial Carcinoma

(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 ...