“CAR-T cell therapies are remarkable drugs and are the gold standard for patients,” said Rachel Haurwitz, PhD, President & CEO of Caribou Biosciences. These […]
BIO 2026: Realizing the promise of CAR-T cell therapies 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 »
Experts at the BIO International Convention examine the growth of the 340B drug pricing program, duplicate discounts, patient access, and calls for greater transparency.
BIO 2026: 340B faces growing calls for transparency, patient-focused reform Read More »
From sickle cell disease to multiple sclerosis and childhood leukemia, patients and advocates reflected on becoming pioneers in therapies that are changing medicine.
BIO 2026: ‘I am alive today because of biotech’ Read More »
At a time when U.S. biotech leadership is being challenged, the patent system that enables life-saving innovations is beset by a toxic stew of
BIO 2026: Biotech threatened by pressures on patent protection Read More »
Industry and government leaders at BIO 2026 said stronger biotechnology policy, regulatory modernization, and public-private partnerships are essential to maintaining U.S. leadership in biotech
BIO 2026: American biotech leadership protects patients and national security Read More »
What started as a conversation, in a bar, written on a napkin in 1976, between biochemist Dr. Herbert W. Boyer and investor Robert A.
After 50 years of biotech, can AI help answer the next impossible question? Read More »
