Two new pancreatic enzyme products used to help aid food digestion, Ultresa ( pancrelipase ) and Viokace ( pancrelipase ), were approved by the U.S. Food and Drug Administration.

The Food and Drug Administration approved GINTUIT , the first cell-based product made from allogeneic human cells (from a donor unrelated to the patient) and bovine collagen.

Korlym ( mifepristone ) was approved by the U.S. Food and Drug Administration to control high blood sugar levels (hyperglycemia) in adults with endogenous Cushing’s syndrome.

The U.S. Food and Drug Administration (FDA) is informing the public that the use of stomach acid drugs known as proton pump inhibitors ( PPIs ) may be associated with an increased risk of Clostridium difficile–associated diarrhea ( CDAD ).

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...

The U.S. Food and Drug Administration (FDA) continues to evaluate the risk of progressive multifocal leukoencephalopathy ( PML ), a rare but serious brain infection, associated with use of Tysabri ( natalizumab ) for the treatment of multiple sclerosis (MS) and Crohn's disease.

ProStrakan Group plc , a subsidiary of Kyowa Hakko Kirin Co. Ltd. and an international specialty pharmaceutical company, announced that it has received approval from the U.S. Food and Drug Administration (FDA) for Rectiv (nitroglycerin) Ointment 0.4% for the treatment of moderate to severe pain associated with chronic anal fissures.

US Nutrition, of Ronkonkoma , New York is recalling Daily Multiple for Women 50 + Tablets, because certain lots contain undeclared fish (fish gelatin). People who have an allergy or severe sensitivity to fish run the risk of a serious or life-threatening allergic reaction if they consume these products.

The U.S. Food and Drug Administration today approved Dificid ( fidaxomicin ) tablets for the treatment of Clostridium difficile-associated diarrhea ( CDAD ).

The FDA is warning health care professionals that Teva - a drug used to treat gut problems like heartburn - can clog syringes and feeding tubes, which can end up harming patients.