FDA names Dexcom as the first participant in its new Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pilot.
Two Sheppard attorneys say an FDA proposal to require complete safety and risk information within the content of direct-to-consumer radio and TV ads w...
Attorney Jake Leys says MDUFA 6 reauthorization has moved from negotiations into writing the commitment letter that spells out all that FDA and the me...
FDA approves GSK's Jideytro (zidesamtinib) for certain adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer.
FDA sends an untitled letter to Sanofi Vaccines U.S., alleging that promotional emails for its respiratory syncytial virus prevention product Beyfortu...
Novo Nordisk sues Lilly in New Jersey federal court over what the company says is a misleading national ad campaign that compares the two companies GL...
FDA warns Indias Shimoga Chemicals about CGMP deviations in its production of active pharmaceutical ingredients.
FDA warns Indias Alembic Research Center that it failed to obtain informed consent for an in vivo bioequivalence study.
