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WASHINGTON , Dec. 15, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for imsidolimab, a novel IgG4 IL-36 receptor antagonist, to treat generalized pustular psoriasis (GPP). Imsidolimab inhibits IL-36 receptor signaling, addressing the deficiency in the e...
WASHINGTON , Dec. 11, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the company will participate in the J.P. Morgan Healthcare Conference in San Francisco, California on Thursday, January 15, 2026.
WASHINGTON , Dec. 4, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on protocol VP-VLY-686-3403, which until today limited the protocol to a maximum of 90 doses of tradipitant. The lift followed Vanda's formal dispute resolution request and an expedited re-review conducted by CD...
Vanda reported strong phase 2 results for a candidate that could be used with GLP-1 drugs. However, this medicine's potential target market appears small and may shrink further.
FDA requests, and Vanda agrees to, a brief extension (to December 5, 2025) for the expedited re-review of the partial clinical hold on long-term studies Separately, FDA recently issued labeling comments, and labeling discussions have formally begun for the New Drug Application of tradipitant for the prevention of vomiting induced by motion (PDUFA target action date remains December 30, 2025) WA...
Vanda Pharmaceuticals stands at a pivotal point, leveraging strong Fanapt growth and a robust late-stage pipeline for future expansion. VNDA's aggressive investment in commercial infrastructure has driven 31% Fanapt sales growth, but resulted in higher cash burn and quarterly losses. Key regulatory catalysts loom with PDUFA dates for Bysanti and tradipitant, and tradipitant's GLP-1 adjunct pote...
Vanda's Tradipitant Study Success Positions it as Key Adjunct in $50B+ Global GLP-1 Agonist Market WASHINGTON , Nov. 17, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA), a leading biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced positive topline results from its randomized controlled clinical study (VP-VLY...
WASHINGTON , Nov. 5, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the company will participate in the Stifel 2025 Healthcare Conference in New York City on Wednesday, November 12, 2025. A corporate presentation is scheduled for 4:40 p.m.
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