Recon: FDA approves Zenbexus for multiple myeloma; NSAI seeks buyer for its MDR notified body business

A busy FDA and regulatory news roundup highlights several approvals, policy moves, and EU and global developments. In the U.S., FDA approval coverage includes Bristol Myers’ myeloma drug milestone tied to an acquisition from Celgene and mentions FDA leadership overruling a clinical review team regarding Replimune’s Tudriqev. Other items include FDA modernization of drug product packaging assessments with a risk-based framework and a September CDRH meeting focused on AI and digital health regulatory science gaps. The roundup also notes NSAI seeking an “orderly exit” from its MDR notified body business, along with multiple international updates such as EMA filings and FDA class-risk proposals for device accessories.