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,
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.
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.
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.
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 ...
FDA bans red dye No. 3 from food, drinks and ingested drugs in the US
Red dye No. 3 is found in at least dozens of candy, food and beverage products, but some of the most popular brands either ...
FDA bans Red No. 3 in food and ingested drugs. Here's when it has to be phased out by
Red No. 3, also known as erythrosine, is a color additive made from petroleum that gives foods and drinks a bright, cherry-red color.
Cowboy State Daily6h
Montana Fitness Guru Faces Jail For Selling Unapproved Drugs To Fight Man Boobs
A Montana fitness-based business owner faces jail time for illegally selling bodybuilding drugs that fight "man boobs." He ...
Targeted Oncology57m
FDA Clears 225Ac-SSO110 for Phase 1/2 SCLC and Merkel Cell Carcinoma Trial
The FDA has approved the investigational new drug application of 225Ac-SSO110, allowing for the start of a phase 1/2 trial in ...
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, ...
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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 ...