Clinical

Articles

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.

GlaxoSmithKline Halts RSV Vaccine Trials in Pregnant Women

Some have expressed concerns about the risk of myocarditis and unknown longer-term side effects.

Concerns About Childhood COVID-19 Vaccines Persist, Despite FDA Committee OK

Developed by Regeneron Pharmaceuticals and Sanofi, Dupixent reduced severe asthma attacks and improved lung function in children 6 to 11 years.



FDA Approves Dupixent for Children with Asthma

Rethmyic is a one-time regenerative tissue-based therapy for children born without a thymus gland.

FDA Approves First Therapy for Rare Immune Disorder


An FDA decision is expected in late 2022.


Janssen Submits Application for Stelara for Psoriatic Arthritis in Children

The enzyme replacement therapy treats Pompe disease, a rare genetic disorder that affects children.

Sanofi Selects Orsini as Limited Distribution Partner for Nexviazyme

The FDA assigned a PDUFA action date of March 20, 2022, for ganaxolone.


Pediatrics