Salix Pharmaceuticals announced that the Food and Drug Administration has accepted for filing a new drug application for Budesonide 2 mg Rectal Foam for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge.
The Food and Drug Administration has postponed the time it will decide whether or not to approve an experimental treatment under development by Takeda Pharmaceutical Co. for ulcerative colitis, the company said.
An expert panel at the Food and Drug Administration has given a thumbs-up to an experimental drug made by Takeda Pharmaceutical Co. for treating ulcerative colitis and Crohn's disease, the drug maker said.
More patients with an inflammatory disease of the bowels responded to a drug used for autoimmune disorders than those taking a placebo, according to results of a late-stage clinical trial announced Monday.
Findings from a new study indicate that more than half of the patients with ulcerative colitis who received subcutaneous injections of a drug used to treat autoimmune disorders responded to the treatment.
Prasco Labs will distribute an authorized generic version of an ulcerative colitis treatment made by Shire in the event that any other company steps forward to file an abbreviated new drug application for the drug.