Pharmaceutical and biopharma regulatory landscapes remain dynamic, with key FDA approvals and delays impacting drug availability. The FDA delayed Bayer’s menopause therapy review, while Geneoscopy secured streamlined FDA clearance for its RNA-based colorectal cancer screening. The European Commission allocated €403 million to advance AI-based medical devices. Amid tariff and pricing shifts, industry executives emphasize strategic operational agility to navigate uncertainties. Legal challenges persist surrounding U.S. price control mechanisms. Additionally, Calidi Biotherapeutics announced a reverse stock split effective August, reflecting market repositioning efforts.