FiercePharma

In letter to RFK Jr., Democrats flag threats to drug review process from FDA firings

It hasn’t yet been two weeks since Robert F. Kennedy Jr. took his post as Department of Health and Human Services (HHS) secretary, but letters from lawmakers outlining their concerns about the ...
MedPage Today on MSN

Five leaders in one year: FDA's drug center enters 2026 at a crossroads

The FDA appointed George Tidmarsh, MD, PhD, to be the nation's top drug official in July. The Center for Drug Evaluation and Research (CDER) has since cycled through another two leaders in 5 months.
Nasdaq

Vanda Seeks FDA Commissioner Review of Outgoing CDER Director's Decision to Uphold Approval of Two Generic Versions of Hetlioz®

WASHINGTON, Aug. 21, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that it has asked Martin Makary, the Commissioner of the U.S. Food and Drug Administration ...
MarketWatch

Vanda Seeks FDA Commissioner Review of Outgoing CDER Director's Decision to Uphold Approval of Two Generic Versions of Hetlioz(R)

WASHINGTON, Aug. 21, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that it has asked Martin Makary, the Commissioner of the U.S. Food and Drug Administration ...