FDA inspection

Catalent rebrand Catalent HQ Tampa Florida FL new Catalent HQ headquarters
Manufacturing

FDA hit Catalent's Maryland manufacturing sites with Form 483

The observations tied to two April FDA inspections came before Catalent's layoff spree at its Maryland gene therapy manufacturing business.
Zoey Becker Dec 19, 2025 11:36am
red light stop light street traffic signal

Alvotech plant issues trigger another FDA biosimilar rejection

Nov 4, 2025 7:40am
FDA

Novo plant issues may mean delays for Regeneron, Scholar Rock

Oct 13, 2025 3:48pm
FDA

J&J subsidiary slapped with FDA warning letter

Sep 23, 2025 2:22pm
FDA

Novo plant acquired in Catalent deal lands in FDA's crosshairs

Aug 22, 2025 10:49am
FDA stop sign

FDA snubs Ultragenyx gene therapy over manufacturing issues

Jul 14, 2025 10:16am