Speaking at a Sept. 9 media briefing on the newly released Make America Healthy Again Strategy, U.S. Health and Human Services Secretary Robert Kennedy confirmed what could be the worst fears of many vaccine experts.

The U.S. FDA issued new guidance for the development of non-opioid analgesics for chronic pain indications, with specific details on trial design, patient populations and meaningful outcomes, including reducing the nation’s reliance on opioids.

It took a memo from the president for the U.S. FDA to begin reining in direct-to-consumer prescription drug advertising with its feel-good messaging and hurried recitation of a few serious adverse events.

Less than two months after receiving priority review status for an NDA, Johnson & Johnson won U.S. FDA approval of Inlexzo, its intravesical gemcitabine-releasing system previously known as TAR-200, to treat adults with Bacillus Calmette-Guérin-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary tumors.

The European Commission (EC) posted a call for evidence regarding its intent to “simplify EU rules” for medical technology with a comment period that began Sept. 8, 2025. Stakeholders almost immediately flooded the docket with recommendations.

The U.S. Office of Inspector General said in a recent report that independent testing labs should be required to develop emergency preparedness plans for public health emergencies, a move that would affect industry giants such as Laboratory Corporation of America and Quest Diagnostics Inc.

Speaking at a Sept. 9 media briefing on the newly released Make America Healthy Again Strategy, U.S. Health and Human Services Secretary Robert Kennedy confirmed what could be the worst fears of many vaccine experts.