FDA warns Madrid, Spain-based Sedecal about Quality System violations in its production of mobile digital radiography systems.
After issuing a safety alert in April, FDA follows up with a Warning Letter to Kabe Labortechnik, the German manufacturer of the RAM Scientific SAFE-T...
Harvard University health policy professor Benjamin Sommers calls on Congress to stand up against cuts in the federal workforce that he says are hurti...
Prothena discontinues the development of birtamimab, its investigational treatment for AL amyloidosis, after the drug failed to meet primary or second...
HHS removes Covid-19 vaccine recommendations for healthy children and healthy pregnant women from CDCs recommended immunization schedule.
FDA places a clinical hold on a Rocket Pharmaceuticals Phase 2 pivotal trial for RP-A501, an investigational gene therapy for Danon disease, following...
FDA gives 510(k) clearance to the latest Olympus endoscopes that feature new extended depth of field technology.
FDA issues Savara a Refusal-to-File (RTF) letter for its BLA for Molbreevi (molgramostim) inhalation solution for treating autoimmune pulmonary alveol...
