Search results
Results From The WOW.Com Content Network
In the United States, the Food and Drug Administration (FDA) determines the requirements for patient package inserts. In the United States, the FDA will occasionally issue revisions to previously approved package inserts, in much the same way as an auto manufacturer will issue recalls upon discovering a problem with a certain car.
Gilteritinib was granted orphan drug status by the U.S. FDA, the European Commission (EC) and the Japan Ministry of Health, Labor and Welfare, for some AML patients. [12] Gilteritinib was approved for medical use in Australia in March 2020. [13]
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.
Emtricitabine exhibits clinical activity against the hepatitis B virus (HBV), but is not approved by the U.S. Food and Drug Administration (FDA) for the treatment of HBV infection. [5] Among individuals with chronic HBV infection, emtricitabine treatment results in significant histologic, virologic, and biochemical improvement.
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage.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.
Decitabine/cedazuridine was approved for medical use in the United States and Canada in July 2020, [7] [8] [9] [12] and in the European Union in September 2023. [6]The U.S. Food and Drug Administration (FDA) granted the application of decitabine combined with cedazuridine priority review and orphan drug designation.
The US FDA approved nedosiran based on evidence from a clinical trial which included 29 participants with primary hyperoxaluria type 1. [3] Nedosiran was evaluated in one clinical trial of 29 participants with primary hyperoxaluria type 1 who were nine years of age and older. [3]
In January 2023, the US Food and Drug Administration (FDA) approved zanubrutinib for chronic lymphocytic leukemia or small lymphocytic lymphoma. [19] In March 2024, FDA granted accelerated approval to zanubrutinib, in combination with obinutuzumab, for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. [20] [21]