Regenxbio reaches an agreement with FDA on a path toward a potential accelerated approval of Navsunli (clemidsogene lanparvovec-sngl), the first gene ...
A new journal article finds substantial differences in how major international regulators evaluate and approve oncology drugs that first receive exped...
Former FDA commissioner Scott Gottlieb urges federal health officials to restore scientific leadership at the agency's medical product centers.
Former FDA Office of New Drugs director Peter Stein criticizes the agency's National Priority Voucher program at the DIA Global Annual Meeting in Phil...
HHS unveils a broad, department-wide initiative aimed at speeding clinical research, reducing regulatory barriers, and attracting more clinical trials...
FDA posts a draft guidance outlining how sponsors can use quantitative systems pharmacology models to determine starting doses for first-in-human clin...
FDA publishes a revised draft guidance that updates how sponsors can demonstrate "substantial evidence" of effectiveness for new drugs and biologics, ...
The agency releases a revised draft guidance aimed at helping sponsors design and conduct clinical trials using master protocols, a trial framework in...
