VANDA PHARMACEUTICALS INC. v. FOOD AND DRUG ADMINISTRATION et al

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Case Number:

1:24-cv-02514

Court:

District Of Columbia

Nature of Suit:

Other Statutory Actions

Judge:

Amit P. Mehta

Firms

Companies

Government Agencies

Sectors & Industries:

  1. July 20, 2026

    Vanda's NDA Rejection Challenge Can't Be Heard At DC Court

    A D.C. federal judge has said he no longer has jurisdiction to hear Vanda Pharmaceuticals Inc.'s challenge alleging the FDA violated the Appointments Clause by allowing a non-officer to exercise "signatory authority" and reject its new drug application for tradipitant, since Vanda went to the D.C. Circuit raising the same argument already.

  2. July 14, 2026

    Judge Says Vanda-FDA Appointments Fight Likely Ripe

    A D.C. federal judge said he likely had jurisdiction to hear Vanda Pharmaceuticals' latest challenge to the Food and Drug Administration's structure for reviewing new drug applications, but wondered if a recent U.S. Supreme Court decision might doom the company's challenge on the merits.