A Food and Drug Administration (FDA) pilot program to expedite approval of new drugs contains potentially impactful initiatives but risks adding burdens, says the […]
BIO applauds efforts targeting early drug development efficiency, provides suggestions Read More »
An agreement designed to shape the future of drug approval recommends new efficiencies while leaning into the existing strengths of a system that makes
PDUFA letter stresses stability, transparency, maturity, says BIO negotiator Read More »
For people living with psoriatic disease, treatment innovation has advanced dramatically. Yet too many patients remain undiagnosed, untreated, or undertreated. The National Psoriasis Foundation
Connecting more patients with psoriasis to the care they need Read More »
BIO’s response to a request for information from the Drug Price Working Group explains why price setting won’t work. Improving patient access to new
Build patient access by strengthening innovation, BIO tells senators Read More »
Biotech innovation provides better-than-average salaries and pumps hundreds of billions of dollars into the U.S. economy annually—and the societal benefits of this innovation can
Studies show value of biotech IP for the economy and society Read More »
There was bipartisan support for the PASTEUR Act’s approach to addressing AMR and for NSCEB recommendations, both BIO priorities. A bipartisan Senate hearing sought
Senators seek solutions for AMR, maintaining US biotech leadership Read More »
The FDA’s Pharmacy Compounding Advisory Committee (PCAC) will consider this week whether seven unapproved peptides should be added to the Section 503A Bulk Drug
FDA Advisory Committee to weigh whether to expand compounding of unapproved peptides Read More »
While the U.S. Food and Drug Administration (FDA) has faced significant change in recent years, industry leaders and agency officials alike say there are
BIO 2026: FDA leaders discuss restoring workforce, institutional knowledge Read More »
A new proposal to regulate federal grants risks destabilizing the system of government support essential to developing innovative therapies American patients need, the Biotechnology
BIO expresses concerns over proposed OMB rule to regulate federal grants Read More »
Industry leaders at BIO 2026 discussed the proposed PDUFA VIII next steps. After a year of discussion with the industry and 127 meetings with
BIO 2026: Industry PDUFA negotiators describe their agreement with FDA Read More »
