Key regulatory discussions are underway focusing on the Prescription Drug User Fee Act (PDUFA) reauthorization and Medicare drug pricing policies. FDA leaders, along with industry representatives from BIO and PhRMA, have convened to deliberate strategies impacting drug approvals and market access. Meanwhile, the Trump administration is finalizing rules regarding Medicare Part D Most Favored Nation (MFN) pricing. These policy developments hold significant implications for pharmaceutical pricing transparency, market dynamics, and future drug development incentives.