FDA News and Regulatory Updates

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.

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.

Camouflaging e-cigarettes as kid- and teen-appealing drinks and toys may help youth conceal the products from adults, increase risk of harm to children.

The second GLP-1 mimetic-based drug approved for chronic weight management, tirzepatide may outperform semaglutide, the first.

The novel potassium-competitive acid blocker is the first new treatment approved for the potentially cancer-producing GI disease in 30 years.

The Pfizer product is the first vaccine indicated to prevent the 5 most common serogroups causing meningococcal disease in adolescents and young adults.

The FDA cites insufficient evidence to show the products would be beneficial for adults switching to vaping from combustible tobacco products or quitting.

The Novavax COVID-19 vaccine is refreshed with 2023-2024 formula targeting the XBB.1.5 strain.

The addition of ileus as a potential adverse event associated with the GLP-1 mimetic is not the first required for the class by the regulator.

The US Food and Drug Administration granted BTD to pegozafermin for the treatment of patients with NASH.

Empagliflozin is approved to lower the risk of sustained decline in eGFR, end-stage kidney disease, CV death, and hospitalization in adults with CKD at risk of progression.

Resmetirom, a once-daily oral, thyroid hormone receptor (THR)-β selective agonist, targets key underlying NASH pathophysiology in the liver.