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In early 2023, the U.S. Food and Drug Administration (FDA) granted accelerated approval to a new Alzheimer’s drug called Leqembi. (Biogen, a biotechnology company, and Eisai, a pharmaceutical ...
After a lull of nearly 2 decades, the Food and Drug Administration (FDA) has approved some novel drugs for the treatment of Alzheimer’s disease since 2021.
A newly approved drug for the treatment of atopic dermatitis could make a big difference to people with moderate-to-severe eczema. Image credit: Sascha Lotz/picture alliance via Getty Images.
The Food and Drug Administration has approved lecanemab, a drug developed by Eisai and Biogen with the goal of slowing the progression of Alzheimer’s disease. FDA grants full approval to new ...
Glasdegib was approved for medical use in the United States in December 2018. [5] [6] [9] [10] [11]FDA approval was based on a multicenter, open-label, randomized study (BRIGHT AML 1003, NCT01546038) that included 115 subjects with newly-diagnosed AML who met at least one of the following criteria: a) age 75 years or older, b) severe cardiac disease, c) baseline Eastern Cooperative Oncology ...
Mirikizumab, a drug currently approved by the Food and Drug Administration (FDA) for the treatment of ulcerative colitis, also sends Crohn's disease into clinical remission, new findings suggest.
A second calicheamicin-linked monoclonal antibody, inotuzumab ozogamicin (marketed as Besponsa), an anti-CD22-directed antibody-drug conjugate, was approved by the U.S. Food and Drug Administration on August 17, 2017, for use in the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. [5]
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.
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