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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,
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 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.
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
14h
on MSN
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 ...
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 ...
thecardiologyadvisor.com
1d
2024 Novel Drug and Biological Product Approvals
The list includes several groundbreaking therapies that are expected to change the treatment landscape for several diseases and conditions.
BioSpace
17h
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, ...
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 ...
4h
Incyte And Syndax : FDA Approves Niktimvo 9 Mg And 22 Mg Vial Sizes
Incyte (INCY) and Syndax Pharmaceuticals (SNDX) announced that the U.S. Food and Drug Administration has approved Niktimvo ...
16h
J&J Initiates Bid for FDA Approval of TAR-200 in Bladder Cancer
The New Brunswick, N.J., pharmaceutical giant said the FDA accepted the application through its Real-Time Oncology Review program, which allows for an earlier submission of topline efficacy and safety ...
FiercePharma
2d
JPM25: BridgeBio's cardiomyopathy drug is off to a roaring start
Less than two months after scoring what analysts deemed a "best-case" FDA approval for its cardiomyopathy drug Attruby, ...
BioPharma Dive
13h
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 ...
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