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August 01, 2022
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.
June 08, 2022
Dupixent is the first biologic medicine approved to treat moderate-to-severe atopic dermatitis from infancy through adulthood.
May 11, 2022
The FDA needs more time to assess information submitted by the company.
March 03, 2022
The setback for GlaxoSmithKline comes amid a multicompany race to develop a vaccine against respiratory syncytial virus infections.
October 28, 2021
Some have expressed concerns about the risk of myocarditis and unknown longer-term side effects.
October 22, 2021
Developed by Regeneron Pharmaceuticals and Sanofi, Dupixent reduced severe asthma attacks and improved lung function in children 6 to 11 years.
October 13, 2021
Rethmyic is a one-time regenerative tissue-based therapy for children born without a thymus gland.
October 08, 2021
An FDA decision is expected in late 2022.
September 30, 2021
The enzyme replacement therapy treats Pompe disease, a rare genetic disorder that affects children.
September 21, 2021
The FDA assigned a PDUFA action date of March 20, 2022, for ganaxolone.