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FDA says the Medtronic recall of HVAD batteries for electrical faults is Class 1.[ Price : $8.95]
CDERs Office of Pharmaceutical Quality issues an upbeat outlook for drug quality in its FY 2021 annual report, with data on drug m...[ Price : $8.95]
Novartis says it is suspending branapalm dosing in a Phase 2b trial of the drug in adults with Huntingtons Disease due to side eff...[ Price : $8.95]
Iovance Biotherapeutics initiates a rolling BLA for lifileucel, a tumor infiltrating lymphocyte therapy for use in patients with a...[ Price : $8.95]
FDA warns Redmond, OR-based Oregons Wild Harvest about CGMP violations in its manufacturing, packaging, labeling, and holding of d...[ Price : $8.95]
Several international pharmaceutical regulatory organizations, including FDA, issue a joint reflection paper on efforts toward bui...[ Price : $8.95]
Pfizer says it will seek regulatory approval this fall for its respiratory syncytial virus prefusion F vaccine candidate.[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension entitled Export of Medical Devices; Foreign Letters ...