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