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.

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.

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

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) ...

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.

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