FDA Accepts RHHBY's sNDA for Gazyva in Treating Lupus Nephritis
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The FDA has accepted Roche's supplemental New Drug Application (sNDA) for Gazyva to treat lupus nephritis, based on positive data from a late-stage study showing a complete renal response benefit.
March 05, 2025 | 5:00 pm
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Roche's sNDA for Gazyva in treating lupus nephritis has been accepted by the FDA, indicating potential for expanded use and increased sales if approved.
The FDA's acceptance of the sNDA suggests a positive regulatory outlook for Gazyva, which could lead to expanded indications and increased sales. The late-stage study data supporting the application further strengthens the case for approval.
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