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FDA Raises the Evidence Bar for Rare Disease Biotechs: Jan 2025 to Apr 2026 Analysis
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Key Takeaways An FDA In Chaos, But the Dust May Be Settling Starting mid 2025, a great deal of biopharma media attention has centered on FDA rejections of rare disease medicines as the administration’s new leaders have replaced the once predictable, career scientist-driven agency. Vinay Prasad announced his plan to depart the Center for Biologics (CBER) in March 2026 (for the second time), and despite the search for his replacement nearing its end, uncertainty remains…
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Convergence of US FDA & Drug Pricing
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The FDA, under new leadership, is taking an unprecedented role in drug pricing by linking approval incentives—like Priority Vouchers—to economic impact and Most Favored Nation (MFN) pricing. This blurs the traditional separation between regulatory review and payer negotiation, pressuring prices from day one. These shifts could reshape biopharma valuations, launch strategies, and access dynamics. Companies must closely track policy changes and strengthen development plans that demonstrate meaningful clinical and economic value.
