Vanda Pharmaceuticals
FDA again rejects Vanda’s Hetlioz for jet lag after yearslong dispute and ‘long‑shot’ re‑review
Vanda Pharmaceuticals; Hetlioz; tasimelteon; jet lag disorder; FDA rejection; supplemental NDA; decision letter; phase advance protocol; circadian rhythm; clinical trial design; collaborative framework agreement; D.C. Circuit ruling; label expansion; sleep disorder drug; regulatory dispute
Vanda Pharmaceuticals Secures FDA Approval for NEREUS (Tradipitant), First New Motion Sickness Drug in Over 40 Years
Vanda Pharmaceuticals; FDA approval; NEREUS; tradipitant; motion sickness; vomiting prevention
Vanda Ends Lawsuits Against FDA in Broad Settlement, Paving Way for Drug Review Progress
Vanda Pharmaceuticals; FDA; Hetlioz; jet lag disorder; tradipitant; lawsuit dismissal; collaborative framework; clinical trial hold; drug approval; sNDA; motion sickness
Federal Appeals Court Overturns FDA Rejection of Vanda’s Hetlioz for Jet Lag Disorder
Vanda Pharmaceuticals; Hetlioz; FDA; jet lag disorder; Federal Appeals Court; supplemental New Drug Application (sNDA); regulatory law; clinical trial evidence
Vanda Pharmaceuticals Rejects Cycle’s Second Takeover Bid Amid FDA Rejection of Tradipitant
Vanda Pharmaceuticals, Cycle Pharmaceuticals, takeover bid, FDA rejection, tradipitant, gastroparesis, biopharma, acquisition offer
Vanda Pharmaceuticals Receives FDA Rejection for Gastroparesis Treatment, Criticizes Agency’s Decision
Vanda Pharmaceuticals, FDA rejection, gastroparesis treatment, tradipitant, conclusory refusal
Vanda’s Fanapt Secures Second FDA Approval for Treating Bipolar I Disorder
Fanapt, Vanda Pharmaceuticals, Bipolar I Disorder, Second FDA Nod, Iloperidone, Acute Treatment of Manic or Mixed Episodes