An HHS contingency plan says FDA would experience sharp reductions in operations if Congress fails to reach a deal to fund the government.
FDA posts an International Council for Harmonization draft guideline entitled E20 Adaptive Designs for Clinical Trials that provides recommendations o...
FDA issues an updated alert about an ongoing Class 1 recall of certain BD Alaris Pump Module infusion sets due to device performance issues.
FDA commissioner Marty Makary tells agency employees that they are protected from planned mass workforce firings if a government shutdown goes into ef...
FDA posts a draft guidance to help drugmakers design clinical trials for treatments targeting disseminated coccidioidomycosis, also known as Valley Fe...
Larimar Therapeutics reports encouraging long-term data from its open-label study of nomlabofusp, an investigational therapy for Friedreichs ataxia.
Novo Nordisk refiles its BLA for Awiqli (insulin icodec), a once-weekly basal insulin injection for adults with Type 2 diabetes.
FDA tells IO Biotech not to submit a BLA for its experimental cancer vaccine Cylembio based on results from a recently completed Phase 3 trial in adva...
