[ 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 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...[ Price : $8.95]
FDA marks the 50th anniversary of the 1976 Medical Device Amendments by highlighting the laws lasting role in shaping the modern o...[ Price : $8.95]
FDA issues an update on a Philips Respironics device correction involving its Trilogy Evo platform ventilators, citing risks that ...