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FDA approval
Pharma
PTC wins FDA approval for brain-delivered gene therapy Kebilidi
The gene therapy has already been approved to treat AADC deficiency in Europe and the U.K., among other countries, where it's branded as Upstaza.
Zoey Becker
Nov 14, 2024 11:31am
Iterum nabs FDA approval for oral UTI drug after prior rejection
Oct 25, 2024 2:52pm
Astellas wins class-first gastric cancer nod for Vyloy
Oct 18, 2024 3:39pm
Judge upholds MSN's generic Entresto nod amid Novartis challenge
Oct 17, 2024 2:59pm
FDA approves Pfizer's injected Hympavzi for hemophilia A or B
Oct 11, 2024 4:20pm
IntraBio hits the ground running with new rare disease launch
Sep 30, 2024 3:25pm