The approval was based on data from the randomized, double-blind, placebo-controlled phase 3b AVA-PED-301 trial.

SAP-001 is an investigational oral agent designed to reduce serum uric acid levels by targeting a distinct renal urate reabsorption transporter.

No difference in mortality risk seen for GLP-1 RA and SGLT2i users; significantly lower risk seen for GLP-1 RA vs DPP4i users.

The recall of more than 160,000 bottles of levothyroxine sodium, which went into effect June 20, was upgraded to a Class II recall on July 23. Class II recalls occur when use of the drug poses a ...

Researchers say findings point to gaps in prenatal HIV detection; the majority of infants not treated for HIV infection after birth were Black.

The single-arm, open-label DR-OVP-002 study is currently evaluating Ovaprene in sexually active women aged 18 to 40 years who ...

Gefurulimab is a dual-binding nanobody designed to bind to the C5 protein in the terminal complement cascade and prevent the overactivation of the body’s immune system.

The goal of the federally recognized definition is to provide consistency in research and policy to address health concerns associated with these foods ...

AD109 is an investigational oral therapy that combines aroxybutynin, an antimuscarinic, with atomoxetine, a selective norepinephrine reuptake inhibitor.

HealthDay News — The US Food and Drug Administration has announced a plan to revoke 52 food standards after concluding they ...

Researchers recommended that regulators consider mandating head-to-head trials comparing next-in-class and against existing in-class agents when possible.

HealthDay News — The US Food and Drug Administration has appointed George Francis Tidmarsh, MD, PhD, as director of the Center for Drug Evaluation and Research (CDER).