FDA Announces Recall on More Than 80,000 Keurig Coffee Pods

The U.S. Food & Drug Administration (FDA) has announced a recall of more than 80,000 coffee pods sold by Keurig Dr Pepper.

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 ...

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.
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 ...
CURE

FDA Clears Phase 3 Trial of iSCIB1+ for Advanced Melanoma

The U.S. Food and Drug Administration (FDA) has cleared an investigational new drug application for a registrational phase 3 clinical trial of iSCIB1+ for patients with advanced melanoma, a step that ...
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 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 ...

Low-risk estradiol treatment comes with an FDA-boxed warning

I’m a 70-year-old woman who has suffered with vaginal dryness ever since I went through menopause. My doctor has prescribed a ...
Marijuana Moment

Top Federal Drug Official Touts Therapeutic ‘Promise’ Of Psychedelics And Slams Schedule I Research Barriers

A top federal health official is again touting the therapeutic “promise” of psychedelics such as psilocybin and MDMA—though ...

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 ...