प्राथमिक स्रोत रिकॉर्ड
महत्वपूर्णआवेदन जमा
DBV Technologies ने VIASKIN Peanut Patch की BLA को 2026 की तीसरी तिमाही तक टाला
DBV will now file its BLA for the VIASKIN Peanut Patch in children 4-7 years old in Q3 2026 instead of an earlier timeline. The delay follows extensive pre-submission dialogue with the FDA to optimize CMC and biostatistical data organization. FDA has not requested any additional clinical data.
मुख्य तथ्य
- फाइल किया गया
- 29 जून 2026, 08:28 pm
- घटना
- आवेदन जमा
- दिशा
- तटस्थ
- कंपनी
DBVTDBV Technologies- संपत्ति
- VIASKIN Peanut Patch
- स्रोत
- SEC 8-K
- विश्वसनीयता
- स्रोत सहित
स्रोत का अंश
EX-99.1 2 d108693dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 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 time to incorporate the FDA feedback and anticipates submitting the BLA in the third quarter of 2026 • DBV will host a co
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