Vanda Pharmaceuticals

Vanda Pharmaceuticals has dosed the first patient in a first-in-human clinical trial evaluating VCA-894A, an antisense oligonucleotide therapy designed for a specific patient with Charcot-Marie-Tooth disease Type 2S.

Vanda Pharmaceuticals has petitioned the U.S. Supreme Court to overturn the FDA's decision denying fast-track approval for tradipitant, its gastroparesis treatment candidate.

• Recent government efficiency cuts at the FDA appear to be causing delays in drug approval timelines, with 66% of healthcare professionals surveyed expressing concern about potential PDUFA date postponements. • Stealth BioTherapeutics' treatment for rare Barth syndrome, elamipretide, has experienced an unexplained decision delay, with no typical safety or manufacturing concerns cited as reasons for the postponement. • Industry experts warn that while widespread disruption isn't yet evident, continued FDA resource constraints could significantly impact clinical trial oversight and create approval backlogs lasting years.

The FDA has missed its April 29 deadline to decide on Stealth Biotherapeutics' elamipretide for Barth syndrome, with no new decision date announced yet.

Vanda Pharmaceuticals has accused FDA officials of unlawfully delaying a hearing on its gastroparesis drug tradipitant, claiming the agency is using recent staff reductions as a false excuse for a six-month postponement.

Vanda Pharmaceuticals has submitted a New Drug Application to the FDA for Bysanti (milsaperidone), seeking approval for the treatment of acute bipolar I disorder and schizophrenia.

FDA Acting Commissioner Sara Brenner has denied Vanda Pharmaceuticals' request for a hearing on Hetlioz (tasimelteon) for sleep-onset insomnia, citing lack of adequate trial data.

Vanda Pharmaceuticals secures exclusive global licensing rights to imsidolimab from AnaptysBio in a deal worth up to $50 million, including $15 million upfront payment and potential milestone rewards.

The FDA has granted Orphan Drug Designation to VGT-1849A, a selective antisense oligonucleotide JAK2 inhibitor, for treating polycythemia vera (PV).

The FDA issued a Complete Response Letter for Vanda Pharmaceuticals' tradipitant, a neurokinin-1 receptor antagonist, for treating gastroparesis, citing insufficient evidence of efficacy.