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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.
July 25, 2021
Keytruda gets a full approval in endometrial cancer; while Xeljanz will miss another PDUFDA date.
July 21, 2021
Azstarys is approved to treat patients 6 years and older.
