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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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Industry Leaders Scott Roberts and John “Zeke” Czekanski Launch MOMENTUS Biopharma Consulting
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LANTANA, Fla., Nov. 5, 2025 /PRNewswire/ — Industry leaders Scott Roberts and John “Zeke” Czekanski announced today they have partnered to form MOMENTUS Biopharma Consulting, LLC (“MOMENTUS” or “the Company”), a purpose-built strategic consulting group. Headquartered in Lantana, FL with an additional location in Boston, MA, MOMENTUS offers integrated strategic solutions across the therapeutic life cycle, sharpening the focus on value and driving better outcomes for patients. The MOMENTUS platform will strive to harness new technologies, leverage Artificial Intelligence (AI), while offering human-input…

