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The U.S. Food and Drug Administration (FDA) approved Journavx (suzetrigine) oral tablets on Thursday as a first-in-class non-opioid analgesic to treat acute pain in adults.
The drug, suzetrigine, received the FDA's official stamp of approval Thursday to be sold as a 50-milligram prescription pill taken every 12 hours, according to a press release.
A new type of non-opioid painkiller, aimed at treating short-term pain in adults, has been approved by the US Food and Drug Administration (FDA). The drug suzetrigine, known by its brand name ...
Aducanumab, sold under the brand name Aduhelm, is an anti-amyloid drug designed to treat Alzheimer's disease. It is a monoclonal antibody that targets aggregated forms (plaque) of amyloid beta (Aβ) found in the brains of people with Alzheimer's disease to reduce its buildup. [10] It was developed by Biogen and Eisai. [11] Aducanumab is given via intravenous infusion. [5] Aducanumab was ...
Daprodustat was approved for medical use in Japan in June 2020, [5] [6] and in the United States in February 2023. [2] [3] [7] [8] making it the first oral treatment for anemia caused by chronic kidney disease for adults in the US. [3] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [9]
The 21st Century Cures Act modified the FDA Drug Approval process. It was intended to expedite the process by which new drugs and devices are approved by easing the requirements put on drug companies looking for FDA approval on new products or new indications on existing drugs.
New research also suggests the inhibitors may reduce the risk of dementia in people with type 2 diabetes after longer-term use. Bisphosphonates Bisphosphonates, scoring 11 out of 12, treat ...
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.
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