प्राथमिक स्रोत रिकॉर्ड
महत्वपूर्णआवेदन जमा
DBV Technologies ने VIASKIN Peanut Patch की BLA को Q3 2026 तक टाला
DBV Technologies now plans to submit its BLA for the VIASKIN Peanut Patch in children aged 4-7 years in Q3 2026 rather than an earlier timeline. The company received FDA feedback on CMC and biostatistical data formatting and organization but no request for additional data. The delay is intended to incorporate this feedback to optimize the review process.
मुख्य तथ्य
- फाइल किया गया
- 29 जून 2026, 08:00 pm
- घटना
- आवेदन जमा
- दिशा
- तटस्थ
- कंपनी
DBVTDBV Technologies- संपत्ति
- VIASKIN Peanut Patch
- विश्वसनीयता
- स्रोत सहित
स्रोत का अंश
DBV Technologies Provides BLA Submission Update for the VIASKIN® Peanut Patch in Children Aged 4 through 7 Years; Working Collaboratively with FDA to Optimize Review Process in Preparation for Filing Châtillon, France, June 29, 2026 DBV Technologies Provides BLA Submission Update for the VIASKIN® Peanut Patch in Children Aged 4 through 7 Years; Working Collaboratively with FDA to Optimize Review Process in Preparation for Filing DBV has been engaged in extensive discussions with the FDA in preparation of its BLA for the VIASKIN® Peanut Patch in children aged four through seven years The objective of the detailed, iterative engagement was to ensure a complete, efficient, and timely FDA review of the BLA, once submitted The Agency has not requested additional data DBV will take additional t
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