The original NDA submission included data from the registration-directed phase 3 MOVE-FA trial as well as 2 long-term studies evaluating vatiquinone in FA.

The extension was needed to review newly submitted long-term clinical data for all patients in the pivotal study following an FDA information request.

Pemvidutide is currently being evaluated in the phase 2 RECLAIM study, which is enrolling approximately 100 patients with AUD and obesity or overweight.

In October 2024, Imuldosa received approval from the Food and Drug Administration based on data from the phase 3 Opportuniti study.

HealthDay News — Differences across blood pressure (BP) measurement methods show clinically important variance in readings, according to a review published online August 19 in the Annals of Internal ...

Semaglutide linked to increased risk of nonarteritic anterior ischemic optic neuropathy, but evidence remains insufficient to establish definitive conclusion.

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to ifinatamab deruxtecan for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) ...

Findings showed inclacumab did not statistically significantly reduce the rate of VOCs compared with placebo after 48 weeks. Topline data were announced from a phase 3 study evaluating inclacumab, an ...

The approval was supported by data from 3 double-blind, placebo-controlled trials that included a total of 1474 patients who met the 2016 ACR criteria for diagnosis of fibromyalgia.

The approval was based on Part 1 (72 week data) of the randomized, double-blind, placebo-controlled phase 3 ESSENCE trial.

The Food and Drug Administration (FDA) has granted Orphan Drug designation to dusquetide (SGX945) for the treatment of Behçet disease, a type of vasculitis characterized by mucocutaneous symptoms (eg, ...

Imagined speech signals were weaker than attempted speech but still accurate enough to reach up to 74% recognition in real time.