FDA News

The label expansion for semaglutide, based on the SELECT trial, includes data showing reduced risk of CV death of 15% and of death from any cause of 19%.

The surprise request for review of the phase 3 TRAILBLAZER-ALZ-2 clinical trial findings will delay the original PDUFA timing beyond first quarter 2024.

The Dexcom system is for adults over the age of 18 years who do not use insulin, such as individuals with T2D who use oral medications, a US population of 25 million.

Biosimilars Wyost and Jubobonti were approved as interchangeable for Xgeva and Prolia but launch will depend on the outcome of litigation between reference product manufacturers.

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.