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Flurpiridaz F-18 is a fluorine 18-labeled agent developed by Lantheus Medical Imaging for the diagnosis of coronary artery disease. [6]The efficacy and safety of flurpiridaz (18 F) were evaluated in two prospective, multicenter, open-label clinical studies in adults with either suspected CAD (Study 1: NCT03354273) or known or suspected CAD (Study 2: NCT01347710). [3]
Piflufolastat (18 F) was approved for medical use in the United States in May 2021. [1] [6] [4] It is the second PSMA-targeted PET imaging drug approved by the U.S. Food and Drug Administration (FDA). [4] The first approved PSMA-targeted PET imaging drug is Ga 68 PSMA-11. [4]
Despite these challenges, Fluosol-DA was approved by the FDA and was marketed as a blood substitute in the United States from 1989 through 1994 when it was withdrawn from the market due to poor sales. [16] Perftoran was approved in the Soviet Union in 1994 and remained in limited use in Russia at least as late as 2019. [17]
ICG was developed in the Second World War as a dye in photography and tested in 1957 at the Mayo Clinic for use in human medicine by I.J. Fox. After being granted FDA approval in 1959, ICG was initially used primarily in hepatic function diagnostics and later in cardiology. In 1964, S. Schilling was able to determine renal blood flow using ICG.
According to the press release from the FDA, businesses will have between 60 and 90 days, depending on their size to stop the distribution of their off-brand products. The FDA's decision is a win ...
The Food and Drug Administration has just approved a generic form of a type 2 diabetes drug in the same class as Ozempic. It's too soon to tell, but it might help reduce the price of these drugs ...
Piflufolastat F-18 was approved for medical use in the United States in May 2021. [1] [6] [4] It is the second PSMA-targeted PET imaging drug approved by the U.S. Food and Drug Administration (FDA). [4] The first approved PSMA-targeted PET imaging drug is Ga 68 PSMA-11. [4]
A study of radiation-induced skin injuries was performed in 1994 by the U.S. Food and Drug Administration (FDA) [58] [59] followed by an advisory to minimize further fluoroscopy-induced injuries. [60] The problem of radiation injuries due to fluoroscopy has been further addressed in review articles in 2000 [61] and 2010. [62]