Clinical

Articles

Eylea is being reviewed as a treatment for retinopathy in premature infants.

FDA Grants Six Months Pediatric Exclusivity for Eylea

Regulators used a re-analysis of data from an observational case-control study of Tdap vaccine effectiveness to show that Boostrix given in the third-trimester prevented pertussis among infants.

FDA Uses Real-World Data to Approve Boostrix for Prevention of Infection in Infants


If approved, trofinetide will be the first drug available for the treatment of Rett syndrome, a rare, genetic neurological disorder mostly in girls. The FDA action date is March 12, 2023.


 FDA Accepts NDA for Rett Syndrome Drug

A clinical trial showed Dyanavel XR tablets were bioequivalent to the extended-release oral suspension formulation of Dyanavel.

Tris Pharma Launches Dyanavel XR Tablets for ADHD

Xofluza is a single-dose, oral therapy and is now approved for children five years and older for both the treatment and prevention of influenza.

FDA Approves Xofluza to Treat and Prevent Flu in Children

The updated PDUFA date is Feb. 28, 2023, and the planned advisory committee meeting is on hold pending review of NDA amendments.

FDA Extends Review of Omaveloxolone in Friedreich’s Ataxia

Stelara is the first biologic targeting both cytokines IL-12 and IL-23 and offers a therapeutic option for children six years of age and older living with active psoriatic arthritis, a rare disease.




FDA Approves Stelara in Children with Psoriatic Arthritis


Dupixent is the first biologic medicine approved to treat moderate-to-severe atopic dermatitis from infancy through adulthood.


FDA Approves Dupixent for Young Children with Atopic Dermatitis

Denise Myshko is your editorial contact for the Formulary Watch. She joined Formulary Watch as editor is June 2021 from Oncology Live. Prior to that, she was managing editor of PharmaVOICE, a trade publication in the pharmaceutical industry. Email: dmyshko@mjhlifesciences.com

The FDA needs more time to assess information submitted by the company.

FDA Extends Review Time for Pompe Disease Therapy

The setback for GlaxoSmithKline comes amid a multicompany race to develop a vaccine against respiratory syncytial virus infections.

Pediatrics