The approval was based on phase 3 data from the randomized, double-blind, placebo-controlled CAHtalyst adult study and CAHtalyst pediatric study.

The Breakthrough Therapy designation is supported by data from the randomized, open-label phase 2 SOLSTICE trial.

The sBLA submission included results from the randomized, parallel-arm, placebo-controlled and active-controlled trial foresiGHt.

Compared with placebo, obicetrapib lowered LDL-C by 33% at day 84 ( P <.0001). Changes in other biomarkers, including high-density lipoprotein cholesterol (HDL-C), non-HDL-C, lipoprotein (a), ...

Number of people with at least one episode of HSV-attributable genital ulcer disease was 187.9 and 16.7 million for HSV-2, HSV-1 in 2020 ...

The FDA is expected to decide on treatments for EBV-positive posttransplant lymphoproliferative disease, breast cancer, Barth syndrome, pain, and migraine.

Findings seen among children and adolescents with type 1 diabetes and nonoptimal control with traditional treatment ...

A higher risk of liver transplant and death was observed in Ocaliva-treated patients vs those who received placebo.

(HealthDay News) — Adults receiving chiropractic spinal manipulative therapy (SMT) for tension-type headache have a significantly lower likelihood of butalbital prescription, according to a study ...

The burden of respiratory syncytial virus (RSV) in young children continues to be high in the United States, according to a study published online Dec. 9 in JAMA Pediatrics. Heidi L. Moline, MD, MPH, ...

SER-155 is an oral, 16-strain microbiome therapeutic that works by decolonizing gastrointestinal pathogens, strengthening the epithelial barrier, and inducing immune tolerance.

A Prescription Drug User Fee Act target date of July 24, 2025 has been set for the sNDA application. The Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) ...