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Regenxbio reaches an agreement with FDA on a path toward a potential accelerated approval of Navsunli (clemidsogene lanparvovec-sn...[ Price : $8.95]
A new journal article finds substantial differences in how major international regulators evaluate and approve oncology drugs that...[ Price : $8.95]
Former FDA commissioner Scott Gottlieb urges federal health officials to restore scientific leadership at the agency's medical pro...[ Price : $8.95]
Former FDA Office of New Drugs director Peter Stein criticizes the agency's National Priority Voucher program at the DIA Global An...[ Price : $8.95]
FDA posts a draft guidance outlining how sponsors can use quantitative systems pharmacology models to determine starting doses for...[ Price : $8.95]
FDA publishes a revised draft guidance that updates how sponsors can demonstrate "substantial evidence" of effectiveness for new d...[ Price : $8.95]
The agency releases a revised draft guidance aimed at helping sponsors design and conduct clinical trials using master protocols, ...[ Price : $8.95]
HHS unveils a broad, department-wide initiative aimed at speeding clinical research, reducing regulatory barriers, and attracting ...