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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.
August 12, 2019
While FDA recently said Novartis and AveXis did not reveal data on their $2.1 million gene thaerpy for pediatric spinal muscular atrophy until after it was approved, Novartis is defending its actions.
February 05, 2019
December 11, 2018
Two major drug recalls in the last week include an expanded recall of a widely used blood pressure medication as well as over-the-counter infant ibuprofen.
May 24, 2018
FDA is asking manufacturers to immediately stop selling OTC products containing the pain reliever benzocaine (such as Orajel) for teething in infants or children.
