US suitability petition submissions see an uptick against the backdrop of GDUFA III new goals for the FDA's response to such petitions. The Pink Sheet tracks some of the activity as applicants seek to tap market opportunities without the need for new clinical data.

Small sterilizers told Medtech Insight that they were ready for the EPA’s controversial EtO emissions rule, while community advocates expressed concerns.

Kyverna CEO Peter Maag spoke with Scrip about the company’s five-year overnight success after its well-received IPO. Metagenomi and Telomir also went public in the US in smaller offerings.

Public Company Edition: Alto Neuroscience and Fractyl Health grossed $128.6m and $110m, respectively, while FibroBiologics went public in a direct listing. Also, Vaxcyte grossed $862.5m in a follow-on offering, Immunocore grossed $350m in a note sale and Vera raised $287.5m.