sNDA – Talk Bio

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

FDA Rejects Lundbeck and Otsuka’s Rexulti for PTSD on Insufficient Efficacy Evidence

3 weeks ago talkbio0Tagged brexpiprazole, Clinical Trials, Complete, Drug Approval, Lundbeck, Otsuka, Post-Traumatic Stress Disorder, Response Letter, Rexulti, sertraline, sNDA, United States Food and Drug Administration

FDA; Rexulti; Lundbeck; Otsuka; PTSD; brexpiprazole; sertraline; Complete Response Letter; sNDA; clinical trials; drug approval

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