Crohn's disease, FDA and Eli Lilly Receives

US FDA approves expanded use of Lilly's bowel disease drug
Eli Lilly said on Wednesday the U.S. health regulator has approved its drug to treat adults with moderate-to-severe Crohn's disease, a type of chronic inflammatory bowel disease (IBD). The drug, branded as Omvoh,
Eli Lilly Receives FDA Approval for Crohn’s Disease Treatment
Eli Lilly said it received Food and Drug Administration approval for its treatment for moderate to severely-active Crohn’s disease, an inflammatory bowel disease that causes chronic abdominal pain.
50 new drugs received FDA approval in 2024
The US Food and Drug Administration approved 50 new molecular entities in 2024 —just five fewer than it did in 2023. Last year’s number of drug approvals is similar to what the agency achieved in other years in the 2020s,
FDA approves first new schizophrenia drug in more than 30 years
The FDA has approved Cobenfy, a new drug to treat people with schizophrenia that comes with fewer side effects.
FDA approves new drug for advanced Parkinson’s Disease
Thousands of Americans are diagnosed every year with Parkinson’s Disease. It’s a movement disorder that affects the central nervous system. Tremor is a common symptom. The Food and Drug Administration recently approved a new drug for those living with advanced Parkinson’s.
Simulations Plus Supported Development of Majority of FDA-Approved Drugs in 2024
SLP highlighted its impact on the pharma industry through support of the development of a majority of the drugs approved by the U.S. FDA in 2024.
FDA Okays LLY's Omvoh for Second Inflammatory Bowel Disease Condition
Eli Lilly and Company LLY announced that the FDA has granted approval to its drug, Omvoh (mirikizumab), for its second inflammatory bowel disease (IBD) condition, Crohn's disease (“CD”), in the United States.
Lilly gets FDA approval for Omvoh for Crohn's disease
Eli Lilly (NYSE:LLY) has received FDA approval for its drug Omvoh, also known as mirikizumab-mrkz, for the treatment of moderately to severely active Crohn's disease in adults. The drug was previously approved in 2023 for the treatment of moderately to severely active ulcerative colitis in adults.
Billed as nonaddictive, new pain pill could soon win FDA approval
A non-opioid painkiller from Vertex Pharmaceuticals could become a blockbuster, but questions remain on whether it will prove ...
Atara Shares Sink After FDA Stalls Cancer Treatment
Atara Biotherapeutics shares plunged after the FDA rejected its application to bring a blood cancer treatment to market. Shares of the biotechnology company were recently down 46.5% to $7.04. The ...
healthday3h
So, Who Benefits From New Cancer Drugs?
Cutting-edge targeted therapies are pushing back the line between life and death for cancer patients.However, these ...
FDA Approves Weight-loss Drug Zepbound For Sleep Apnea – Will Insurance Cover This $1000-Per-Month Medication?
Zepbound is a dual-activating medication that combines glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like ...
BioSpace1d
Inspector General Questions FDA’s Accelerated Approval for Biogen, Sarepta Drugs
An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, ...
BioPharma Dive23h
Federal watchdog cites concerns with FDA’s accelerated approval process
The review, which was spurred by controversy over the FDA's Aduhelm approval, recommends two main changes in agency ...
Becker's Hospital Review17h
Watchdog flags flaws in FDA's fast-track drug approvals
The OIG report points to gaps in documentation and decision-making transparency, particularly in the case of Aduhelm, where FDA records indicated only 13 meetings with Biogen, but congressional ...
Healio1d
FDA clears investigational new drug application for lorundrostat in OSA, hypertension
The FDA approved the phase 2 Explore-OSA trial set to assess the highly selective aldosterone synthase inhibitor, ...