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Amgen. non-small cell lung cancer with KRAS G12C mutation. Avapritinib. Blueprint Medicines Corp. granted for two indications: mast cell leukemia and advanced systemic mastocytosis. Belumosudil. Kadmon Pharmaceuticals. chronic graft-versus-host disease. Pembrolizumab.
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...
Deucravacitinib was approved for medical use in the United States in September 2022, [7] [11] [12] and in Australia in December 2022. [1] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication .
Tirzepatide was first approved by the Food and Drug Administration (FDA) in 2022 and has no generic versions on the market. But when the drug was declared to be in shortage in December that same ...
September 27, 2024 at 2:25 PM. New schizophrenia drug gets FDA approval, taking novel approach to treating brain disorder. A new drug has been approved for the treatment of schizophrenia in adults ...
In July 2021, the U.S. Food and Drug Administration (FDA) granted priority review designation for the biologics license application (BLA) for the Pfizer–BioNTech COVID-19 vaccine with a goal date for the decision in January 2022. [277] [278] On 23 August 2021, the FDA approved the vaccine for use for those aged sixteen years and older. [33 ...
In 2022 Congress investigated the accelerated passage and approval of the Alzheimers drug Aduhelm, manufactured by Biogen and being marketed at $56,000 per patient a year. Although the FDA usually follows an advisory committee's recommendation, the investigation found that the FDA decided to consider it under the accelerated approval pathway ...
[10] [11] [12] The FDA stated that it represents a first-of-its-kind treatment approved for Alzheimer's disease and that it is the first new treatment approved for Alzheimer's since 2003. [3] Aducanumab's approval is controversial for numerous reasons including ambiguous clinical trial results regarding efficacy , the high cost of the ...