Hetlioz – Talk Bio

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Vanda Ends Lawsuits Against FDA in Broad Settlement, Paving Way for Drug Review Progress

1 week ago talkbio0Tagged Clinical Trials, collaborative framework, Drug Approval, Employment Termination, Hetlioz, jet lag disorder, lawsuit, Motion Sickness, sNDA, Tradipitant, United States Food and Drug Administration, Vanda Pharmaceuticals

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

2 months ago talkbio0Tagged Clinical Trials, Evidence, Federal Appeals Court, Hetlioz, jet lag disorder, New Drug Application, regulatory law, sNDA, United States Food and Drug Administration, Vanda Pharmaceuticals

Vanda Pharmaceuticals; Hetlioz; FDA; jet lag disorder; Federal Appeals Court; supplemental New Drug Application (sNDA); regulatory law; clinical trial evidence