Vanda Pharmaceuticals Announces Collaborative Framework for Resolution of Disputes with the U.S. Food and Drug Administration [Yahoo! Finance]
Vanda Pharmaceuticals Inc. (VNDA)
Last vanda pharmaceuticals inc. earnings: 2/25 04:01 pm
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Source: Yahoo! Finance
Food and Drug Administration (FDA) for the resolution of certain disputes regarding HETLIOZ ® (tasimelteon) and tradipitant. Vanda Logo (PRNewsfoto/Vanda Pharmaceuticals Inc.) Key features of the agreement include: The FDA will conduct an expedited re-review of the partial clinical hold preventing long term clinical studies of tradipitant for the treatment of motion sickness by November 26, 2025 . The FDA will continue its review of Vanda's New Drug Application (NDA) for this indication, with the existing Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2025 The FDA will conduct an expedited re-review of Vanda's supplemental New Drug Application (sNDA) for HETLIOZ ® for the treatment of jet lag disorder by January 7, 2026 , including consideration of alternative or narrowed indications focusing on the sleep-related aspects of jet lag disorder. During the re-review, Vanda and the FDA will seek a temporary pause of the Part 12 proceedings that result fro
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VNDA
News
- FDA Lifts Partial Clinical Hold on Tradipitant for Motion Sickness [Yahoo! Finance]Yahoo! Finance
- FDA Lifts Partial Clinical Hold on Tradipitant for Motion SicknessPR Newswire
- Vanda Pharmaceuticals (NASDAQ:VNDA) had its "buy" rating reaffirmed by analysts at HC Wainwright.MarketBeat
- Vanda Pharmaceuticals (NASDAQ:VNDA) was downgraded by analysts at <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=VNDA&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeat">Wall SMarketBeat
- Vanda Pharmaceuticals Provides Regulatory Update on Tradipitant for Motion Sickness [Yahoo! Finance]Yahoo! Finance
VNDA
Earnings
- 10/29/25 - Miss
VNDA
Sec Filings
- 12/4/25 - Form 8-K
- 11/28/25 - Form 8-K
- 10/30/25 - Form 10-Q
- VNDA's page on the SEC website