A Health Affairs article calls on doctors and health systems to take steps to test generic drugs to minimize risks to patients.
A Congressional Research Service report says a 2021 law codified FDAs approach to defining a new chemical entity in regulations including exclusivity....
Five drug companies agree to pay $42 million to settle a Texas enforcement action involving allegedly improper reimbursements for certain pharmaceutic...
FDA grants HuidaGene Therapeutics a rare pediatric disease designation for HG004 and its use in treating inherited retinal disease caused by RPE65 mut...
FDA grants traditional approval for Genentechs Gavreto (pralsetinib) for treating adult patients with metastatic RET (rearranged during transfection) ...
FDA sends Galera Therapeutics a complete response letter on an NDA for avasopasem manganese for radiotherapy-induced severe oral mucositis in patients...
FDA publishes a draft guidance on incorporating QTc prolongation-related information in drug and biological product labeling.
FDA clears a Curiteva 510(k) for the Navigation Instrument System for use with its Prodigy Pedicle Screw System and SI-Lution Sacroiliac Joint Fusion ...
