Vanda submitted its supplemental New Drug Application (sNDA) in October 2018 to market HETLIOZ ® to treat jet lag disorder. After the FDA substantially delayed resolving Vanda's request for a hearing ...
Vanda Pharmaceuticals and the FDA have agreed to lay down their swords, squashing years of legal disputes with an agreement that will see regulatory action on much of Vanda’s grievances. The ...
The FDA has won a legal dispute with Vanda Pharmaceuticals over a partial clinical hold it imposed on tradipitant. Vanda took the FDA to court in the belief the agency's demand ran counter to ...
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