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Crohn's disease, US FDA

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,

YAHOO!Finance · 35m

Lilly gains US FDA approval for Omvoh to treat Crohn’s disease

Eli Lilly has received approval from the US Food and Drug Administration (FDA) for Omvoh (mirikizumab-mrkz) to treat moderately to severely active Crohn's disease in the adult population. This is the second inflammatory bowel disease indication for the therapy in the US, after its approval for ulcerative colitis (UC) treatment in October 2023.

The Wall Street Journal on MSN · 12h

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.

Business Insider · 5h

FDA Approves Lilly's Omvoh For Crohn's Disease Treatment

Eli Lilly and Co. (LLY) announced that the U.S. Food and Drug Administration has approved Omvoh (mirikizumab-mrkz) for the treatment

FDA, accelerated approvals

STAT · 1d

Federal watchdog raises some concerns about the FDA’s accelerated approval program

The Office of Inspector General reviewed the FDA’s use of accelerated approval for 24 drugs, ultimately finding issues with the process for three of them.

BioPharma Dive · 17h

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 procedures.

Becker's Hospital Review · 10h

Watchdog flags flaws in FDA's fast-track drug approvals

A new report from HHS' Office of Inspector General raises concerns about the FDA's accelerated approval process for drugs with weak supporting evidence, Bloomberg reported Jan. 14. The report highlights issues with the approvals of Biogen's Alzheimer treatment,

FDA red food dye ban

NBC News on MSN · 14h

FDA bans Red Dye No. 3, artificial coloring used in beverages, candy and other foods

The Food and Drug Administration said Wednesday it’s banning the use of Red No. 3, a synthetic dye that gives food and drinks their bright red cherry color but has been linked to cancer in animals.

The Associated Press on MSN · 9h

FDA bans red dye No. 3 from foods

U.S. regulators are banning the dye called Red 3 from the food supply. The move comes nearly 35 years after the dye was barred from cosmetics such as lipsticks because of potential cancer risk.

USA Today · 14h

Red No. 3 banned by FDA. The bright-red dye is in these foods, candies and drinks

Your favorite bright red drinks and candies may soon look different as the Food and Drug Administration banned Red No. 3. The dye is in these products.

13d

FDA approves drugs from Vertex, Novo, Bristol Myers to wrap 2024

The agency’s main drug review office cleared 50 novel medicines last year, short of 2018’s record total but on the higher end ...

FiercePharma5d

Breaking down the 55 new drug approvals of 2024

A review of the FDA’s drug approvals of 2024 shows that small companies loomed large—both in the sheer number of nods g | ...

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 ...

13don MSN

The anxious wait for life-changing drug approval

In the UK, the drug has had approval by the MHRA, but is awaiting a decision by NICE, which is expected by August 2025. "If I ...

2don MSN

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 ...

Vertex Pharmaceuticals Sets Sight on Expanding Portfolio with Alyftrek Approval, Pain Treatment Progress, and Diabetes Trials

Vertex secures FDA approval for ALYFTREK and expands TRIKAFTA use, advances diabetes and kidney disease therapies, and ...

15hon MSN

Only FDA-approved vape products are available for purchase in Kentucky. Here's what to know

In 2024, the General Assembly passed House Bill 11, which limits vape products that can be sold in Kentucky. The new law only ...

Hosted on MSN17h

Tempus AI announces national launch of FDA-approved xT CDx test

Tempus AI (TEM) announced the national launch of the company’s FDA-approved, NGS-based in vitro diagnostic device, xT CDx.

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Crohn's disease, US FDA

FDA, accelerated approvals

FDA red food dye ban

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