Regenxbio reaches an agreement with FDA on a path toward a potential accelerated approval of Navsunli (clemidsogene lanparvovec-sngl), the first gene therapy for treating Hunter syndrome, or mucopolysaccharidosis type II.
A new journal article finds substantial differences in how major international regulators evaluate and approve oncology drugs that first receive expedited approval from FDA, despite often reviewing largely the same clinical evidence.
Regenxbio reaches an agreement with FDA on a path toward a potential accelerated approval of Navsunli (clemidsogene lanparvovec-sngl), the first gene therapy for treating Hunter syndrome, or mucopolysaccharidosis type II.
A new journal article finds substantial differences in how major international regulators evaluate and approve oncology drugs that first receive expedited approval from FDA, despite often reviewing largely the same clinical evidence.
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 Philadelphia last week.
