BioWorld

FDA’s CDER helmless again, amid bribery, defamation claims

The U.S. FDA once again has a leadership gap at the top of its drug center, which already has been ravaged this year by massive terminations, resignations and retirements of senior leaders. George ...
Green Matters on MSN

FDA Recalls More Than 140,000 Bottles of Cholesterol Medications Due to High Health Risk They Pose

Massive recall of 141,984 bottles of Cholesterol medicine gets an update. In September, the Food and Drug Administration ...
FiercePharma

FDA official challenges safety, efficacy of Aurinia lupus med in now-deleted LinkedIn post targeting surrogate endpoints

A now-deleted LinkedIn post from a top FDA official has raised the hackles of Aurinia Pharmaceuticals as industry watchers puzzle over the official's decision to target the approvability of surrogate ...
AZ Central

iTolerance, Inc. Appoints Former Chief of the Laboratory of Biochemistry in the FDA’s Center for Drug Evaluation and Research (CDER), Emily Shacter, Ph.D., to its Scientific ...

Esteemed expert in the regulation and development of biopharmaceuticals, with more than three decades of experience spanning government, industry, and academia MIAMI, FL / ACCESS Newswire / August 21, ...
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 ...