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The journal Nature examines the problems with FDAs accelerated approval program and potential reforms to reduce any gaming by the ...[ Price : $8.95]
Federal Register notice: FDA issues a final order to reclassify certain human immunodeficiency virus (HIV) serological diagnostic ...[ Price : $8.95]
BridgeBio Pharma sells for $110 million its priority review voucher that was awarded last year when FDA approved Nulibry (fosdenop...[ Price : $8.95]
FDA sends UCB a complete response letter on its BLA for psoriasis-treating bimekizumab, citing deficiencies from a recent preappro...[ Price : $8.95]
A just-released, scathing (XXX INSERT XXX)23-page Form FDA-483 cites 10 GMP deficiencies at Sun Pharmaceutical Industries Halol ma...[ Price : $8.95]
FDA approves an Eli Lilly NDA for Mounjaro (tirzepatide), a once-weekly injection to improve blood sugar control in adults with Ty...[ Price : $8.95]
FDA clears a BD (Becton, Dickinson) 510(k) for its new automated, high-throughput infectious disease molecular diagnostics platfor...[ Price : $8.95]
FDA approves a Medtronic PMA for the Onyx Frontier drug-eluting stent, indicated for treating patients with coronary artery diseas...