FDA

FDA

Fierce Pharma

Medline earns FDA warning letter ire for repeat bacteria issues

Medline was slammed for a second time since April by an FDA warning letter that outlined the presence of toxic bacteria in finished products.

Joseph Keenan Jun 4, 2026 7:36am

delay

FDA extends Beren’s rare disease review after info request

May 28, 2026 10:45am

FDA delays ruling on AstraZeneca drug after negative adcomm vote

May 27, 2026 4:43am

Open door symbolizing exit

Fierce Pharma

CDER chief Høeg and CBER's Szarama exiting FDA posts

May 15, 2026 1:44pm

Aardvark

Aardvark to dig into phase 3 data early after FDA imposes hold

May 15, 2026 1:51am

FDA

Fierce Pharma

Biopharma rallies behind Pazdur to lead FDA. But is he willing?

May 14, 2026 11:05am