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A Health Affairs article calls on doctors and health systems to take steps to test generic drugs to minimize risks to patients.[ Price : $8.95]
A Congressional Research Service report says a 2021 law codified FDAs approach to defining a new chemical entity in regulations in...[ Price : $8.95]
Five drug companies agree to pay $42 million to settle a Texas enforcement action involving allegedly improper reimbursements for ...[ Price : $8.95]
FDA grants HuidaGene Therapeutics a rare pediatric disease designation for HG004 and its use in treating inherited retinal disease...[ Price : $8.95]
FDA grants traditional approval for Genentechs Gavreto (pralsetinib) for treating adult patients with metastatic RET (rearranged d...[ Price : $8.95]
FDA sends Galera Therapeutics a complete response letter on an NDA for avasopasem manganese for radiotherapy-induced severe oral m...[ Price : $8.95]
FDA clears a Curiteva 510(k) for the Navigation Instrument System for use with its Prodigy Pedicle Screw System and SI-Lution Sacr...[ Price : $8.95]
University researchers say a trend toward FDA approving new drugs based on less rigorous standards is continuing.