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In combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant ...
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage. See the list of FDA-approved therapeutic monoclonal antibodies in the monoclonal antibody therapy page.
Once a drug receives fast track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
A breakthrough therapy designation can be assigned to a drug if "it is a drug which is intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition" and if the preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as ...
Call to action (CTA) is a marketing term for any text designed to prompt an immediate response or encourage an immediate sale. A CTA most often refers to the use of words or phrases that can be incorporated into sales scripts, advertising messages, or web pages, which compel an audience to act in a specific way.
The FDA's decision came as a surprise to company officials and many Alzheimer's experts, who had expected a full approval for Lilly's drug donanemab this month based on clinical trial data last ...
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.
Mounjaro had been on the FDA's list of drugs in short supply since late 2022, while Zepbound was added in April. Compounding facilities create medicines by combining, mixing or altering drug ...