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Pharming says FDA accepts Joenja pediatric sNDA, sets Jan. 30, 2027 PDUFA date
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Pharming says FDA accepts Joenja pediatric sNDA, sets Jan. 30, 2027 PDUFA date
  • Pharming won FDA Priority Review for a Joenja label expansion in APDS to cover children aged 4+ weighing 13 kg to 27 kg.
  • PDUFA action date set for Jan. 30, 2027.
  • Approval would extend access beyond the current U.S. indication for ages 4-11 weighing at least 27 kg.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Pharming Group NV published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202609251030PRIMZONEFULLFEED1001274630) on September 25, 2026, and is solely responsible for the information contained therein.

Disclaimer:This article represents the opinion of the author only. It does not represent the opinion of Webull, nor should it be viewed as an indication that Webull either agrees with or confirms the truthfulness or accuracy of the information. It should not be considered as investment advice from Webull or anyone else, nor should it be used as the basis of any investment decision.
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