The FY 2025 report on GDUFA-funded science and research tells how the research supported the development of product-specific guidances and the approva...
USC associate professor Genevieve Kanter says she is skeptical that the wholesale firing of HHS advisory committee experts to eliminate industry influ...
The National Association of Manufacturers calls on FDA to adhere to statutory and regulatory provisions governing expert panel meetings so stakeholder...
An advocacy group takes aim at FDA, arguing in a new report that the agencys drug review process has grown more costly and restrictive.
Kodiak Sciences says its anti-VEGF therapy Zenkuda (tarcocimab tedromer) hit the mark in a second Phase 3 trial in diabetic retinopathy.
Health experts breakdown a new FDA policy framework that could mark a turning point for highly individualized genetic medicines.
FDA warns Bethesda, MD-based Longhorn Vaccines and Diagnostics about Quality System, Medical Device Reporting, and Adulterated and Misbranded Device v...
FDA asks to look at Rezolutes Phase 3 data after the companys trial of ersodetug missed the primary endpoint, with the hope of charting a clear path f...
