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Ornithine translocase deficiency belongs to a class of metabolic disorders referred to as urea cycle disorders. The urea cycle is a sequence of reactions that occurs in liver cells. This cycle processes excess nitrogen, generated when protein is used by the body, to make a compound called urea that is excreted by the kidneys .
This type of treatment is taken orally. [10] It does not induce an unwanted immune response, and a single type of small molecule could be used to treat many lysosomal storage diseases. [10] Substrate reduction therapy is FDA approved and there is at least one treatment available on the market. [10]
Drug-induced nonautoimmune hemolytic anemia is a form of hemolytic anemia. Non-immune drug induced hemolysis can occur via oxidative mechanisms. This is particularly likely to occur when there is an enzyme deficiency in the antioxidant defense system of the red blood cells.
The Flowflex COVID-19 Antigen Home Test is currently the only at-home COVID test cleared by the FDA’s premarket review pathway. That means this test is approved beyond just emergency use, but ...
The new test received FDA authorization after the company submitted data from clinical trials showing that the First To Know Syphilis Test identified a positive specimen 93.4% of the time.
The FDA's approach leaves a void for American consumers worried about the ingredients or safety of their dietary supplements. Some nonprofit organizations and third-party companies have stepped up ...
Plasminogen, sold under the brand name Ryplazim, is a biologic medication for the treatment of hypoplasminogenemia (plasminogen deficiency type 1). [1] [2] [4] It is purified from human plasma [1] [2] and is administered intravenously.
CDRH is co-creating a prototype home model with an architectural firm, patient groups, healthcare providers, and the medical device industry. This home prototype is necessary to facilitate meaningful innovation in home use devices by jump starting the community in conversation. The prototype is anticipated to be completed in late 2024.