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September 13, 2022
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.
August 17, 2022
A clinical trial showed Dyanavel XR tablets were bioequivalent to the extended-release oral suspension formulation of Dyanavel.
August 12, 2022
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.
August 10, 2022
The updated PDUFA date is Feb. 28, 2023, and the planned advisory committee meeting is on hold pending review of NDA amendments.
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.
