Rep. Abigail Spanberger and 14 Democratic colleagues ask FDA and DEA for more information on their work to resolve shortages of ADHD medications.
FDA lifts a clinical hold against PepGen that will allow the company to begin the Phase 1 FREEDOM-DM1 study of PGN-EDODM1 in patients with myotonic dy...
FDA grants MimiVax a fast track designation for its SurVaxM vaccine that is being studied for treating newly diagnosed glioblastoma.
FDA says it will accept until 12/11 applications for its new Digital Health Technologies Advisory Committee.
Federal Register notice: FDA seeks comments on an information collection entitled Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and ...
A Tufts Center for Biomedical System Design analysis says cell and gene therapies are more likely to be successful than other therapies in specified s...
Two Reed Smith attorneys explain how FDA may grant a breakthrough device designation to medical devices that have the potential to address and improve...
Sen. Richard Blumenthal (D-CT), in a second complaint, urges FDA to join the U.S. Department of Justice to thoroughly investigate whether Philips Resp...
