STAT

Katherine Szarama named acting director of FDA’s vaccines and biologics center

Katherine Szarama, who joined the FDA last year to serve as Vinay Prasad’s deputy, will now fill his shoes at CBER.

New FDA analysis says US infant formula supply is safe after testing for potential contaminants

Federal health officials said a new analysis of U.S. infant formula found reassuringly low levels of heavy metals, pesticides and other potential contaminants. The U.S.

The FDA Just Approved a New Depression Treatment—and It Doesn’t Involve Medication

Known as transcranial direct-current stimulation, or tDCS, the technology is designed for at-home use, potentially offering a more accessible alternative to traditional therapies, according to The New York Times.
MedPage Today

FDA Intensifies Crackdown on GLP-1 Compounding

The surge in GLP-1 compounding began a few years ago when high demand triggered widespread shortages. Shortages of tirzepatide (resolved in December 2024) and semaglutide (resolved in February 2025) have since ended, though liraglutide remains on the shortage list with limited availability.

US FDA approves Axsome's drug for Alzheimer's-related agitation

Food and Drug Administration ‌has approved Axsome Therapeutics' ‌drug to treat agitation in patients ​with Alzheimer's disease, the company said on Friday. The drug, branded as Auvelity, offers a ‌new treatment ⁠option for patients with Alzheimer's-related agitation,

FDA set to pilot test real-time tracking of clinical trials

The Food and Drug Administration (FDA) is set to pilot test real-time clinical trials in the hopes of expediting results and feedback, federal health officials announced on Tuesday. At least two clinical trials by pharmaceutical companies AstraZeneca and Amgen will test the new system to alert FDA officials to study results in real time.