FDA Approval - Search News

Crohn's disease, US FDA

Reuters on MSN · 9h

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,

The Wall Street Journal on MSN · 14h

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.

Pharmaceutical Technology · 3h

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

Eli Lilly has received approval from the US FDA for Omvoh to treat moderately to severely active Crohn's disease in the adult population.

Business Insider · 8h

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

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 · 19h

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 · 12h

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,

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 ...

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 | ...

4d

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 ...

22h

BridgeBio Pharma Is A Buy On Dips After Attruby's FDA Approval

Attruby's approval makes BridgeBio Pharma a competitor to Vyndaqel, with significant potential for growth and milestone ...

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 ...

6d

Independence Blue Cross to exclude coverage for some drugs that get accelerated FDA approval

Independence Blue Cross has instituted an 18-month benefit exclusion on certain drugs that receive accelerated approval from ...

16hon MSN

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 ...

1d

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 ...

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