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FDA gives Rocket Pharmaceuticals an accelerated approval for its gene therapy Kresladi (marnetegragene autotemcel) for children wi...[ Price : $8.95]
FDA sends an untitled letter to STAQ Pharma of Ohio, citing significant manufacturing, quality control, and labeling violations.[ Price : $8.95]
Erbe USA recalls its flexible cryoprobes due to their potential to rupture during activation, which could result in severe injury ...[ Price : $8.95]
Wave Life Sciences reports new interim Phase 1 data Thursday indicating that a 240 mg dose of its investigational obesity therapy ...[ Price : $8.95]
On a CDER guidance recap podcast, master mathematical statistician James Travis explains a new draft guidance on using Bayesian me...[ Price : $8.95]
FDA meeting minutes say agency representatives in the 2/26 PDUFA 8 reauthorization discussion agreed to consider a proposal from i...[ Price : $8.95]
The FY 2025 report on GDUFA-funded science and research tells how the research supported the development of product-specific guida...[ Price : $8.95]
USC associate professor Genevieve Kanter says she is skeptical that the wholesale firing of HHS advisory committee experts to elim...