Nipocalimab, the first and only investigational treatment to be granted U.S. FDA Breakthrough Therapy designation for the treatment of adults with moderate-to-severe Sjögren's disease, has now received Fast Track designation
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Johnson & Johnson's investigational treatment, nipocalimab, has received Fast Track designation from the FDA for treating moderate-to-severe Sjögren's disease. This follows its earlier Breakthrough Therapy designation, highlighting its potential as a significant treatment option.
March 18, 2025 | 12:15 pm
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Johnson & Johnson's investigational drug nipocalimab has been granted Fast Track designation by the FDA for treating Sjögren's disease, following its earlier Breakthrough Therapy designation. This could accelerate its development and approval process.
The Fast Track designation by the FDA is a significant regulatory milestone that can expedite the development and review process of nipocalimab. This increases the likelihood of the drug reaching the market sooner, potentially boosting JNJ's stock price.
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