FDA gives Rocket Pharmaceuticals an accelerated approval for its gene therapy Kresladi (marnetegragene autotemcel) for children with severe Leukocyte ...
FDA sends an untitled letter to STAQ Pharma of Ohio, citing significant manufacturing, quality control, and labeling violations.
Erbe USA recalls its flexible cryoprobes due to their potential to rupture during activation, which could result in severe injury or death.
On a CDER guidance recap podcast, master mathematical statistician James Travis explains a new draft guidance on using Bayesian methodology in drug an...
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...
