[ Price : $8.95]
FDA issues BPI Labs a Form-483 following an April inspection for potential cross-contamination risks at its outsourcing facility i...[ Price : $8.95]
Replimune plans to resubmit its controversial BLA for RP1 (vusolimogene oderparepvec) in combination with Opdivo as a treatment fo...[ Price : $8.95]
DexCom says it has identified two lots of stolen Dexcom G7 continuous glucose monitoring sensors that were diverted into the comme...[ Price : $8.95]
FDA and the drug industry conclude technical negotiations over the next iteration of the Prescription Drug User Fee Act, setting t...[ Price : $8.95]
An FDA crackdown on allegedly deceptive prescription drug advertising leads to a sharp increase in pharmaceutical advertising spen...[ Price : $8.95]
FDA publishes a final guidance to assist sponsors in submitting human factors information with medical device marketing applicatio...[ Price : $8.95]
FDA publishes two final guidances on aspects of establishing bioequivalence.[ Price : $8.95]
Reps. Debbie Dingell and Rich McCormick say FDA should update its strategy for evaluating and identifying sepsis as a means to exc...