FDA Alerts
FDA Gives Thumbs Up to New IBD Rx
The U.S. Food and Drug Administration today approved Entyvio (vedolizumab) injection to treat adult patients with moderate to severe ulcerative colitis and adult patients with moderate to severe Crohn‘s disease.
FDA approves Simponi
The U.S. Food and Drug Administration today approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis.
FDA Approves Humira to Treat Ulcerative Colitis
The U.S. Food and Drug Administration today expanded the approved use of Humira ( adalimumab ) to include treatment of moderate-to-severe ulcerative colitis in adults.
FDA Drug Safety Communication: TNF blockers
The U.S. Food and Drug Administration (FDA) is informing the public that it continues to receive reports of a rare cancer of white blood cells (known as h epatosplenic T-Cell lymphoma or HSTCL ), primarily in adolescents and young adults being treated for Crohn’s disease and ulcerative colitis with medicines known as tumor necrosis factor ( TNF ) blockers, as well as with azathioprine , and/or mercaptopurine .
Crohn's disease and ulcerative colitis cause inflammation of the digestive system. Common symptoms are pain in the abdomen, cramps, and diarrhea. Bleeding from the rectum, wei...