Janssen Submits Supplemental New Drug Application To FDA Seeking Full Approval Of Balversa For Treatment Of Patients With Locally Advanced Or Metastatic Urothelial Carcinoma And Selected Fibroblast Growth Factor Receptor Gene Alterations
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Janssen, a subsidiary of Johnson & Johnson (JNJ), has submitted a supplemental New Drug Application to the FDA for full approval of Balversa. The drug is intended for the treatment of patients with locally advanced or metastatic urothelial carcinoma and selected fibroblast growth factor receptor gene alterations.
August 28, 2023 | 8:16 pm
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POSITIVE IMPACT
JNJ's subsidiary Janssen has submitted a supplemental New Drug Application to the FDA for full approval of Balversa. If approved, this could potentially boost JNJ's revenues.
The news directly pertains to JNJ as Janssen is its subsidiary. If the FDA approves Balversa, it could potentially increase JNJ's revenues, hence the positive score. The importance is high as drug approvals can significantly impact a pharmaceutical company's revenues. The confidence level is set at 80% as the FDA's decision is still pending.
CONFIDENCE 80
IMPORTANCE 75
RELEVANCE 100