Posts Tagged ‘first’


FDA Press Releases: FDA approves first Botulism Antitoxin for use in neutralizing all seven known botulinum nerve toxin serotypes

The U.S. Food and Drug Administration announced today that it has approved Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G)-(Equine) to treat patients showing signs of botulism following documented or suspected exposure to botulinum neurotoxin. The product is derived from horse plasma and contains a mixture of antibody fragments that neutralize all of [...]

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FDA Press Releases: FDA approves first retinal implant for adults with rare genetic eye disease

The U.S. Food and Drug Administration today approved the Argus II Retinal Prosthesis System, the first implanted device to treat adult patients with advanced retinitis pigmentosa (RP). The device, which includes a small video camera, transmitter mounted on a pair of eyeglasses, video processing unit (VPU) and an implanted retinal prosthesis (artificial retina), replaces the [...]

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FDA Press Releases: FDA permits marketing of first test that can simultaneously identify 11 causes of infectious gastroenteritis

The U.S. Food and Drug Administration today allowed marketing for the first test that can simultaneously detect 11 common viral, bacterial and parasitic causes of infectious gastroenteritis from a single patient sample. Food and Drug Administration–Press Releases

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FDA Press Releases: FDA approves first anti-diarrheal drug for HIV/AIDS patients

The U.S. Food and Drug Administration today approved Fulyzaq (crofelemer) to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy, a combination of medicines used to treat HIV infection. Food and Drug Administration–Press Releases

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FDA Press Releases: FDA approves first drug to treat multi-drug resistant tuberculosis

On Dec. 28, the U.S. Food and Drug Administration approved Sirturo (bedaquiline) as part of combination therapy to treat adults with multi-drug resistant pulmonary tuberculosis (TB) when other alternatives are not available. Food and Drug Administration–Press Releases

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