FDA meeting minutes say agency representatives in the 2/26 PDUFA 8 reauthorization discussion agreed to consider a proposal from industry representati...
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.
Wave Life Sciences reports new interim Phase 1 data Thursday indicating that a 240 mg dose of its investigational obesity therapy WVE-007 produced str...
