The U.S. FDA’s Aug. 11, 2025, warning letter to LeMaitre Vascular Inc. discloses that the agency was troubled by what it saw as problems with sterility-related processes used to manufacture the Artegraft device, findings that could complicate relations between the company and its customers.

South Korea’s Ministry of Food and Drug Safety (MFDS) launched a new industry-academia-research consortium to support the nation’s organoid industry, expected to grow in light of the U.S. FDA’s shift away from animal testing in the development of novel drugs.

A few years after it was founded with the aim of taking RNA therapies to the next level, Arnatar Therapeutics Inc. emerged from stealth, disclosing a $52 million series A round raised in 2024 as well as U.S. FDA orphan and rare pediatric disease designations for ART-4, an antisense oligonucleotide candidate targeting the root cause of Alagille syndrome.

Arnatar Therapeutics Inc.’s ART-4, an upregulating antisense oligonucleotide (ASO) therapeutic candidate for the treatment of Alagille syndrome (ALGS), has been awarded U.S. orphan drug and rare pediatric disease designations by the FDA. Approximately 95% of ALGS cases are caused by haploinsufficient mutations in the Jagged-1 (JAG1) gene, leading to insufficient JAG1 protein levels and impaired liver bile duct development.

The U.S. FDA has announced a class I recall for the Wallstent Monorail system by Boston Scientific Corp. of Marlborough, Mass, a device for treatment of carotid artery stenosis. The company advised customers in early July to return any unused inventory because the inner diameter of the stent is narrower than intended, which may lead to difficulties in extracting the delivery device after placement of the stent.

Worrisome new signals caused the U.S. FDA – which earlier this month OK’d revised labeling for Valneva SE’s chikungunya virus vaccine Ixchiq – to suspend the product’s license altogether. Regulators pointed to four added reports of serious adverse events consistent with chikungunya-like illness, and told Valneva, of Saint Herblain, France, that the company must stop U.S. shipping and sales of the product. Shares (NASDAQ:VALN) closed Aug. 25 at $9.43, down $2.21, or 19%.

The U.S. FDA has cleared Artrya Ltd.’s 510(k) for its Salix coronary plaque (SCP) module that is a bolt-on module to the company’s Salix coronary anatomy platform.

Shattuck Labs Inc. has reported that its IND from the U.S. FDA for SL-325 for the treatment of inflammatory bowel disease is now in effect. The company expects to commence a phase I trial in healthy volunteers in the third quarter of this year.