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(Reuters) -The U.S. Food and Drug Administration on Tuesday approved Johnson & Johnson's chemotherapy-free combination treatment for a type of non-small cell lung cancer, setting up a challenge ...
The drug was approved in January under the FDA’s Accelerated Approval pathway, which allows the organization to approve drugs for serious conditions where there is an unmet medical need, based ...
(Reuters) -The U.S. Food and Drug Administration approved Bristol Myers Squibb's schizophrenia drug late on Thursday, making it the first new type of antipsychotic medicine in decades. The ...
The regulator approved the drug for moderate to severe obstructive sleep apnea in adults with obesity, the company said. The approval opens up a wide market of patients for Lilly at a time when ...
A new drug application in the 1930s for sulfapyridine to the United States Food and Drug Administration. The Food and Drug Administration's (FDA) New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing.
The U.S. Food and Drug Administration (FDA) has approved a generic daily injectable for the GLP-1 medication for patients who are 10 years old and up with Type 2 diabetes. The liraglutide ...
The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.
Before a drug can be prescribed, it must undergo the FDA's approval process. While a drug can feasibly be used off-label (for non-approved indications), it still is required to be approved for a specific disease or medical condition. [2] Drug companies seeking to sell a drug in the United States must first test it.