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Three drug company stakeholders suggest changes to research proposed by the CDER Office of Prescription Drug Promotion.[ Price : $8.95]
University of Colorado researchers say they have identified two FDA-approved drugs that may help prevent Alzheimers disease and im...[ Price : $8.95]
FDA grants breakthrough therapy designation to Janssens talquetamab for some multiple myeloma patients.[ Price : $8.95]
FDA publishes a draft guidance to help sponsors develop fit-for-purpose clinical outcome assessment measures of patients health th...[ Price : $8.95]
Federal Register notice: FDA determines for patent restoration purposes the regulatory review period for ViiV Healthcares Rukobia ...[ Price : $8.95]
Federal Register notice: FDA determines for patent term restoration purposes the regulatory review period for Y-mAbs Therapeutics ...[ Price : $8.95]
FDA sets 2/28/23 as the target date for its review of a Regeneron sBLA for a 167-week dosing regimen of Eylea in patients with dia...[ Price : $8.95]
A Duane Morris legal alert says the Justice Department is showing a renewed interest in fraud-on-FDA cases.