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Federal Register notice: FDA issues a priority review voucher to Marinus Pharmaceuticals for gaining approval of a rare pediatric ...[ Price : $8.95]
Federal Register notice: FDA corrects an 8/17 notice on a 10/17-19 hearing request to review and vote on whether agency approval f...[ Price : $8.95]
FDA sends Alvotech a complete response letter on its proposed Humira biosimilar AVT02, citing inspection deficiencies at its Reykj...[ Price : $8.95]
FDA denies most requests in a Salix Pharmaceuticals petition asking for restrictions on approval of ANDAs citing its Xifaxin as th...[ Price : $8.95]
Bayer agrees to pay $40 million to the federal government and 20 states to resolve two whistleblower False Claims Act suits over t...[ Price : $8.95]
FDA releases its 2022 report on advancing regulatory science with updates to the focus areas identified in the 2021 regulatory sci...[ Price : $8.95]
FDA accepts for review a Bausch & Lomb and Novaliq NDA for NOV03 (perfluorohexyloctane), an eye drop therapy for treating the sign...[ Price : $8.95]
FDA clears a Magnus Medical 510(k) for the Saint Neuromodulation System for treating major depressive disorder in adults who have ...