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.
Writing in an online Washington Legal Foundation post, Goodwin Procter partner Matt Wetzel examines a recent appeals court decision that shot down Pfi...
FDA approves Abbotts new Precision Plus spinal cord stimulation system.
