The U.S. Government Accountability Office said in a recent report that the Medicare national coverage determination process could use a few adjustments, but the report also pointed to significant resource problems associated with the process, a source of drag that only Congress can fix.

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.

“The comment I hear a lot from scientists … is that science has no borders,” Arif Noorani, partner at Sidley Austin LLP, said while addressing the panel audience at Asia Bio 2025 in Singapore. “I agree, but the reality is, we do have a lot of borders.”

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.

PMV Pharmaceuticals Inc.’s rezatapopt yielded impressive overall response data in ovarian cancer, prompting the firm to aim for a potential accelerated approval filing in early 2027. The news caused the firm’s stock (NASDAQ:PMV) to jump in premarket trading, but shares ended the day at $1.27, down 20%, as investors signaled they are clearly holding out for further data confirming broader market potential for the p53-targeting small molecule.

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.

Elutia Inc. agreed to sell its Elupro and Cangaroo bioenvelopes for implantable medical devices to Boston Scientific Corp. for $88 million in cash. Elutia will use the funds to further development of NXT-41x, an antibiotic biomatrix designed to reduce post-surgical complications in breast reconstruction.

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.