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WASHINGTON, March 19, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA), a leader in innovative drug development and a vocal advocate for reducing unnecessary animal testing, today voiced serious concerns over the U.S. Food and Drug Administration (FDA)'s new draft guidance, "General Considerations for the Use of New Approach Methodologies in Drug Development," released March 18, 2026, by the Center for Drug Evaluation and Research (CDER). The FDA's draft guidance aims to support the use of New Approach Methodologies (NAMs)—advanced non-animal tools like in vitro assays, organ-on-chip systems, computational models, and human cell-based platforms—to modernize nonclinical testing and move away from traditional animal models.

WASHINGTON, March 3, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has granted the company's request for a formal evidentiary public hearing to review the Center for Drug Evaluation and Research's (CDER) proposal to refuse approval of Vanda's supplemental new drug application (sNDA) for HETLIOZ® (tasimelteon) in the treatment of jet lag disorder. The FDA confirmed the decision to grant a hearing in a letter from the Office of the Commissioner dated March 2, 2026.

WASHINGTON, Feb. 26, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the company will participate in the 2026 Citizens Life Sciences Conference in Miami on Wednesday, March 11, 2026. A corporate presentation is scheduled for 2:15 p.m.

Vanda Pharmaceuticals (NASDAQ: VNDA) shares are up during Wednesday's premarket session following the FDA's approval of Bysanti, a new oral treatment for bipolar I disorder and schizophrenia, as well as the company's rare skin disease drug is under FDA review.

WASHINGTON, Feb. 25, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of its Biologics License Application (BLA) for imsidolimab for the treatment of Generalized Pustular Psoriasis (GPP), with a target action date of December 12, 2026. GPP is a rare, chronic, life-threatening autoinflammatory skin disorder characterized by sudden flares of widespread pustules, erythema, and systemic symptoms such as fever and fatigue.

Vanda Pharmaceuticals Inc. has received FDA approval for BYSANTI, a new atypical antipsychotic targeting bipolar I disorder and schizophrenia. VNDA now markets five products, but BYSANTI's differentiation from Fanapt is questioned due to similar active molecules and looming patent expiry. 2025 saw Fanapt sales up 24%, but VNDA posted a $(220.5m) net loss and expects higher cash burn in 2026, raising funding concerns.

Vanda Pharmaceuticals (NASDAQ: VNDA) opened some 45% higher today after the biotech firm said it has received the FDA's approval for its treatment of schizophrenia and bipolar I disorder. The BYSANTI (milsaperidone) announcement is a welcome reprieve for VNDA that's been under pressure this year as investors weighed “disappointing” Q4 earnings against a backdrop of clinical uncertainty.