The drug was previously approved in 2023 for the treatment of moderately to severely active ulcerative colitis in adults. Lilly (NYSE:LLY) has submitted marketing applications for Omvoh for Crohn ...

Omvoh was approved for its first IBD indication, moderately to severely active ulcerative colitis (“UC”), in 2023. The drug is currently approved for UC in 44 countries.

Eli Lilly has claimed FDA approval for its IL-23 inhibitor Omvoh as a treatment for moderately to severely active Crohn's disease, extending its use beyond ulcerative colitis (UC) for the first time.

Lilly said the new drug – which will be sold under the Omvoh brand – will be launched in the coming weeks. It has already been approved under the same trade name in Europe and Japan ...

Eli Lilly’s Omvoh became the first IL-23 drug approved in ulcerative colitis in October 2023, while AbbVie’s Skyrizi hit the scene as the first IL-23 med cleared by the FDA to treat Crohn’s ...

To get FDA approval, scientists must be able to demonstrate that a new drug or treatment is safe and effective. And currently, before they can test a new therapy in humans, they must show proof ...

INDIANAPOLIS (dpa-AFX) - Eli Lilly and Co. (LLY) announced that the U.S. Food and Drug Administration has approved Omvoh (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn ...

The U.S. Food and Drug Administration has delayed granting full approval of Novavax's COVID-19 vaccine despite it being on track to be cleared until Tuesday afternoon, a person familiar with the ...

The FDA has approved Omvoh for the treatment of moderately to severely active Crohn’s disease, making it the second interleukin-23p19 specific inhibitor approved for both major types of ...

Additionally, positive developments in Lilly's product pipeline, such as FDA approval of Omvoh for Crohn's disease and successful results from studies on Baricitinib for alopecia, provided ...