Vanda Pharmaceuticals Inc. (VNDA) has received a Complete Response Letter from the FDA as part of ongoing review of supplemental New Drug Application for HETLIOZ in the treatment of insomnia characterized by difficulties with sleep initiation. It was previously reported that the FDA identified deficiencies.
Consistent with the prior notification, the FDA has issued a CRL, indicating that the FDA cannot approve the sNDA in its present form. The company stated that it is reviewing the CRL and evaluating next steps.
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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.