FDA inspection

FDA
Manufacturing

J&J subsidiary slapped with FDA warning letter

J&J's subsidiary landed in hot water with the FDA this summer over manufacturing problems at the company’s South Korean plant.
Fraiser Kansteiner 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
Asia

Enhertu, Takeda, Trump—Fierce Pharma Asia

May 9, 2025 6:15am
President Donald Trump speaks to reporters after signing a proclamation in the Oval Office at the White House on April 17 20

Trump, in exec order, tasks FDA with boosting US drug production

May 6, 2025 10:18am
FDA

Compounder in Lilly lawsuit hit with FDA warning letter

Apr 24, 2025 8:20am