This Week at the FDA: Giving Thanks for New FDA Designations

Happy November!

As we recover from Halloween and prepare for Thanksgiving, take a moment to check out some recent FDA announcements.

FDA grants breakthrough therapy designation to UGN-101 for urothelial cancer

A treatment for a rare tumor, occurring mostly in older population, is currently in phase 3 trials. FDA recently granted the developers of the drug a breakthrough designation.

Acer submits new drug application for rare disease to FDA

Vascular EDS is rare, potentially fatal, and difficult to treat. Acer is trying to change this.

Clobazam Oral Film Granted FDA Approval for Lennox-Gastaut Syndrome

Good news for the LGS community! The FDA just approved a new medicine for this rare form of epilepsy.

FDA Rare Pediatric Disease designation for progeria drug

Because children with progeria age faster, they generally pass away in their teenage years. A new possible treatment option was just given a designation to help speed it along.


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