Ultragenyx

FDA

Biotech

FDA plans real-time release of drug rejection letters

Alongside the new policy, the FDA released 89 new complete response letters, adding to the more than 200 that were previously made public in July.

Darren Incorvaia Sep 4, 2025 1:45pm

FDA stop sign

Fierce Pharma

FDA snubs Ultragenyx gene therapy over manufacturing issues

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