What to know about FDA’s review of new Zyn advertising proposal

Americans who smoke may soon be hearing a lot more about Zyn. That's the flavored nicotine pouch that's generated billions in ...
STAT

FDA’s new ‘plausible mechanism pathway’ for personalized gene editing raises concerns

In November, six months after KJ’s debut, top Food and Drug Administration officials Marty Makary and Vinay Prasad published ...
National Law Review

FDA Updates Two Digital Health Final Guidance Documents

On Jan. 6, 2026, the U.S. Food and Drug Administration (FDA) updated the final guidance documents General Wellness: Policy ...

Dr. Roach: Low-risk estradiol treatment comes with an FDA-boxed warning

In my opinion, the risks of estrogen cream like the estradiol you have been prescribed are low. I agree with removing the boxed warning, which can scare women from using these helpful, low-risk ...

The FDA's Hands-Off Approach to Medical AI Is a Win for Health-Conscious Consumers

AI-powered medical wearables and software are flourishing following the FDA’s new hands-off regulatory guidance.
STAT

Excitement and wariness as FDA shifts to much more flexible cell and gene therapy oversight

At a Food and Drug Administration cell and gene therapy (CGT) roundtable last June, most speakers pushed for the agency to ...

FDA weighs allowing Zyn pouches to be marketed as lower-risk nicotine option

Flavored nicotine pouches called Zyn could soon be legally advertised as a lower-risk option for adults who smoke, as federal ...

FDA Eases Wearable Oversight: Industry Leaders React at Newsweek Event

Looser regulations around consumer-grade wearable devices could be a "path to ROI" for health systems—or a "double-edged ...

Legal questions swirl around FDA’s new expedited drug program, including who should sign off

A plan to slash Food and Drug Administration drug review times is raising alarms at the public health agency that's been ...
FOX 5 Atlanta

FDA upgrades cookie recall to highest danger level over undeclared peanuts

The Food and Drug Administration announced that a recall of cookie products has been upgraded to its most serious risk ...