HHS Secretary RFK Jr. is announcing updated FDA standards for pasteurized orange juice. Here is what the 10% Brix shift means ...

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, ...

A Florida biotech company is asking a federal court to require the U.S. Food and Drug Administration (FDA) to act on long-pending export applications, arguing that delays dating back to the Biden ...

The FDA says it can't license Regenative Lab's overseas sales today because it might change its regulations tomorrow. Now, ...

From Indiana to Iceland, the FDA this week disclosed concerns raised during recent visits to a pair of manufacturing sites ...

BOSTON, July 16, 2026 /PRNewswire/ -- HoneyNaps, an AI-based sleep medicine company, today announced that SOMNUM V3.0, its AI diagnosis software for polysomnography (PSG) analysis, has received U.S.

The FDAs enforcement action against Purolea Cosmetics Lab offers an early look at how the agency expects AI-generated work to fit within existing quality systems, with experts saying human oversight ...

IGeneX, Inc., a specialty laboratory focused on tick-borne disease diagnostics today announced study results published in the journal Microbiology Spectrum showing that FDA-cleared innovative ...

While AI shows promise in healthcare, the way some AI tools are tested and approved doesn't generate much confidence.

A Missouri woman has filed a federal lawsuit alleging that a Nevro spinal cord stimulation device implanted to treat chronic ...

Navigating the FDA approval process ranks among the most complex challenges facing manufacturers and distributors of ...

The FDA PreCheck Pilot Program will focus on manufacturing readiness, regulatory predictability, and expedited facility ...