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BIO 2026: FDA leaders discuss restoring workforce, institutional knowledge
While the U.S. Food and Drug Administration (FDA) has faced significant change in recent years, industry leaders and agency officials...
BIO expresses concerns over proposed OMB rule to regulate federal grants
A new proposal to regulate federal grants risks destabilizing the system of government support essential to developing innovative therapies American...
BIO 2026: Industry PDUFA negotiators describe their agreement with FDA
Industry leaders at BIO 2026 discussed the proposed PDUFA VIII next steps. After a year of discussion with the industry...
BIO 2026: 340B faces growing calls for transparency, patient-focused reform
Experts at the BIO International Convention examine the growth of the 340B drug pricing program, duplicate discounts, patient access, and...
BIO 2026: ‘I am alive today because of biotech’
From sickle cell disease to multiple sclerosis and childhood leukemia, patients and advocates reflected on becoming pioneers in therapies that...
BIO 2026: Biotech threatened by pressures on patent protection
At a time when U.S. biotech leadership is being challenged, the patent system that enables life-saving innovations is beset by...