FDA News

Reported adverse events of products with tianeptine include seizures, loss of consciousness, and death, according to the FDA.

The investigational combination opioid from Ensysce Biosciences is designed to deter abuse as well as prevent accidental or intentional overdose, the company said.

Dupilumab is the first agent approved to treat EoE in this vulnerable pediatric population.

The Boxed Warning reflects FDA research into severe adverse events including hospitalization and death in persons with CKD treated with denosumab.

This second shelf-life extension for the OTC naloxone hydrochloride 4 mg spray continues the FDA's campaign to prevent drug overdose and related fatalities.

While the FDA's preliminary evaluation has not surfaced evidence of a link, the agency says it "cannot definitively rule out that a small risk may exist," and so will continue research.

In an open letter to the public, Lilly decries use of tirzepatide products Mounjaro and Zepbound for nonmedical purposes and warns of counterfeit formulations.

If approved the 21-valent shot would be the first pneumococcal conjugate vaccine indicated specifically for adults.

The US FDA approved expanded indications for bempedoic acid and bempedoic acid plus ezetimibe for primary hyperlipidemia.

Crinecerfont was granted FDA breakthrough therapy designation for the treatment of congenital adrenal hyperplasia.