FDA issues an early alert warning healthcare providers about a potentially high-risk device issue involving introducer kits used with Impella heart pu...
FDA warns Amazon it is marketing unapproved new drugs on its Web site.
Former FDA commissioner Scott Gottlieb supports the agency's newly announced initiative to accelerate early-stage clinical trials, arguing that the p...
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...
