After July’s first-ever release of more than 200 complete response letters (CRLs) by the U.S. FDA, the agency now says it will release letters shortly after sponsors receive them. In addition, the FDA released a new batch of 89 CRLs from 2024 to now that are tied to pending or withdrawn applications.

Biogen Inc.’s IND application for BIIB-142 has been accepted by the FDA. BIIB-142 is a degrader of IRAK-4 that Biogen intends to explore for therapeutic use in patients with autoimmune diseases.

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.

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

Telix Pharmaceuticals Ltd. received an FDA complete response letter (CRL) a day after the Aug. 27 PDUFA date for its BLA for radiopharmaceutical renal cancer imaging agent, Zircaix (TLX250-CDx, 89Zr-DFO-girentuximab).