Vanda Pharmaceuticals (VNDA) said it secured a victory over the FDA in its dispute with the agency regarding the approvability of HETLIOZ or tasimelteon to treat jet lag disorder. The Court has remanded the case back to the FDA, where Vanda anticipates the FDA will either approve the sNDA or Vanda will receive a hearing.
Vanda submitted its supplemental New Drug Application in 2018 to market HETLIOZ to treat jet lag disorder. The court ordered the FDA to resolve Vanda's sNDA or commence a hearing.
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Business News
May 22, 2026 14:46 ET Minutes of the latest Fed policy session was the highlight of the week along with survey data on the U.S. housing market. In Europe, survey data signaled the trends in the euro area private sector. Further, consumer price inflation data from the U.K. was in focus. In Asia, various economic indicators from China drew attention to the health of the economy.