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Ultragenyx

FDA stop sign
Favicon Fierce Pharma

FDA snubs Ultragenyx gene therapy over manufacturing issues

The manufacturing-related rejection also delays a key test of the new FDA leadership’s support for cell and gene therapies against rare diseases.
Angus Liu Jul 14, 2025 10:16am
Human skeleton in anatomy classroom

Lack of early win for Ultragenyx’s bone disorder med dents stock

Jul 10, 2025 8:04am
An illustration of a white strand of DNA which lies horizontally across an image

Ultragenyx tweaks gene therapy dosing to dial up efficacy

Oct 4, 2024 8:46am
Go sign green light

Ultragenyx gets green light to seek FDA approval of gene therapy

Jun 13, 2024 5:55am
broken bone fracture break x ray skeleton

Ultragenyx, Mereo's brittle bone drug sustains fracture rate cut

Jun 12, 2024 8:55am
blood test vials

Ultragenyx's ph. 3 win for glycogen storage disease gene therapy

May 30, 2024 4:00pm

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