FDA News

A PDUFA date of June 27, 2024 has been set for approval of a 6th dupilimab indication - as add-on therapy for individuals with COPD and eosinophilic inflammation.

The OUtMATCH trial showed that individuals as young as age 1 year could tolerate small amounts of peanut and other allergens without an allergic reaction.

Approval of the application would extend the current Arexvy indication for prevention of RSV in adults aged 60 years and older; a June 2024 PDUFA date is set.

After March 8, 2024, EUA-labeled Paxlovid will no longer be authorized for use, regardless of expiration date, according to the agency.

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.