Sparks flew both ways Sept. 4 as Democratic senators pushed for Robert Kennedy to resign as secretary of the U.S. Department of Health and Human Services (HHS) during a Senate Finance Committee hearing ostensibly held to discuss the Trump administration’s 2026 health care agenda. But with Kennedy the only witness, the hearing focused on Kennedy’s perceived failings as HHS secretary. “The United States is in the midst of a health care calamity,” Ranking Member Ron Wyden, D-Ore., said in his opening comments, which were laden with personal attacks.

Onco3r Therapeutics BV has obtained clinical trial application (CTA) approval by the Belgian regulatory authorities for its SIK3 inhibitor O3R-5671. A first-in-human trial will be conducted in Belgium and is expected to open enrollment in the coming weeks. Final data are expected in the first half of next year and will inform subsequent patient trials across a range of autoimmune diseases, which are planned to commence next year.

Ideaya Biosciences Inc. has submitted an IND application to the FDA for IDE-892, an MTA-cooperative inhibitor of PRMT5.

Kardium Inc.’s Globe pulsed field system received U.S. FDA premarket approval, making it the fourth PFA system in the rapidly expanding market for cardiac ablation for atrial fibrillation. The system’s introducer sheath and mapping software also received clearance.

The Sept. 3 congressional hearing on AI in health care raised questions about whether the U.S. FDA enjoys the statutory authorities it needs to properly regulate this class of products, but witnesses at the hearing said a lack of trust in AI is a substantial roadblock to adoption.

The vaccine dominoes continue to fall in the U.S. This time one fell on the FDA’s Vaccines and Related Biological Products Advisory Committee, as one of Health and Human Services Secretary Robert Kennedy’s most outspoken critics was removed from the panel nearly a year and a half before his term was to expire.

Oddsmakers placing their bets on which drugs will be in play for round 3 of the U.S. Inflation Reduction Act (IRA) price negotiations are doing some reshuffling, thanks to an orphan drug provision tucked into the Trump administration’s One Big Beautiful Bill Act (OBBBA) that was signed into law on the Fourth of July.

Medtronic plc reported that its soon-to-be spun out diabetes business scored two key regulatory wins.