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Vanda Pharmaceuticals Announces Collaborative Framework for Resolution of Disputes with the U.S. Food and Drug Administration
- Vanda Pharmaceuticals Inc. announced a collaborative framework with the U.S. Food and Drug Administration for resolving disputes regarding HETLIOZ® and tradipitant.
- The FDA will conduct an expedited re-review of the partial clinical hold on tradipitant by November 26, 2025.
- Vanda will dismiss its lawsuits challenging the FDA's decisions on tradipitant and HETLIOZ®, as part of this collaborative agreement.
- The FDA will continue its review of Vanda's New Drug Application for tradipitant, with a deadline of December 30, 2025.
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Vanda Pharmaceuticals Announces Collaborative Framework for Resolution of Disputes with the U.S. Food and Drug Administration
WASHINGTON, Oct. 1, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that it has agreed on a collaborative framework with the U.S. Food and Drug Administration (FDA) for the resolution of certain disputes regarding HETLIOZ® (tasimelteon) and…
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Total News Sources43
Leaning Left3Leaning Right4Center13Last UpdatedBias Distribution65% Center
Bias Distribution
- 65% of the sources are Center
65% Center
15%
C 65%
R 20%
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