FDA approves Teva Pharmaceuticals and Alvotechs Selarsdi injection as an interchangeable biosimilar to Janssens reference biologic Stelara (ustekinuma...
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...
Sen. Eric Schmitt introduces legislation to create an inspector general for FDA and two other public health agencies.
FDA announces a 5/20-21 Oncologic Drugs Advisory Committee meeting to review and vote on four cancer drug submissions.
FDA announces a 5/22 Vaccines and Related Biological Products Advisory Committee meeting to discuss and make recommendations on the selection of the 2...