FDA grants Italfarmaco a fast track designation to givinostat for treating patients with polycythemia vera, a rare hematologic cancer.
FDA commissioner Michael Makary says the agency is rolling out a generative AI-assisted scientific review tool to all Centers by 6/30.
A northern Texas judge rules in FDAs favor in a case challenging its decision last year to remove Eli Lillys weight loss and diabetes drugs Zepbound a...
SS Innovations says it will seek a de novo marketing authorization in July for its SSi Mantra 3 surgical robotic system.
Former CDER Office of Compliance director Don Ashley says inspection disruptions caused by recent FDA reductions in force will not rise to the level o...
Theriva Biologics reports positive Phase 2b VIRAGE topline results for its VCN-01 when added to standard of care chemotherapy to treat a form of pancr...
A Moderna Phase 3 study says its combination mRNA flu and Covid-19 vaccine achieved a greater immune response than comparator standard of care vaccine...
FDA accepts for review an Omeros BLA resubmission for narsoplimab for treating hematopoietic stem cell transplant-associated thrombotic microangiopath...
