fda
Washington (AFP) - The US Food and Drug Administration has given the green light for a popular anti-obesity drug to be used to prevent serious heart conditions for the first time, in a move likely to expand insurance coverage. Wegovy, produced by Danish pharmaceutical giant Novo Nordisk, was approved "to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and either obesity or overweight," the FDA said in a statement. The FDA's decision could be a game changer for the approximately 70 percent of American adults who it says are either obese or ...
AFP
Washington (AFP) - The US drug regulator gave full approval to a new Alzheimer's medicine on Thursday, a move that makes it more widely available to the public through government-run health insurance for the elderly. Leqembi, developed jointly by Japan's Eisai and Biogen of the United States, was shown in a clinical trial to modestly reduce cognitive decline among patients in the early stages of the disease. But the study also raised concerns about side effects including brain bleeds and swelling. Leqembi was initially granted "accelerated approval" by the Food and Drug Administration in Janua...
AFP
Washington (AFP) - The US Food and Drug Administration has approved a fast-acting nasal spray from Pfizer designed to treat migraines, the US pharmaceutical giant said Friday. Pfizer said it expected the drug, marketed under the name Zavzpret, to be available in pharmacies in July 2023. "The FDA approval of Zavzpret marks a significant breakthrough for people with migraine who need freedom from pain and prefer alternative options to oral medications," Pfizer chief commercial officer Angela Hwang said in a statement. A Phase 3 study of the drug found that it delivered pain relief to some migrai...
AFP
Washington (AFP) - The US Food and Drug Administration on Friday approved a highly anticipated new drug designed to slow cognitive decline in patients in mild and early stages of Alzheimer's disease. The FDA approval of the drug, Leqembi, also known as lecanemab, comes just days after the regulatory agency was harshly criticized in a congressional report for its green-lighting of another Alzheimer's drug, Aduhelm. And it was granted despite trial results showing the monoclonal antibody treatment carries risks of brain swelling and bleeding. Both drugs were approved through an accelerated proce...
AFP
Washington (AFP) - A US panel of independent experts voted unanimously Friday in favor of recommending Johnson & Johnson's one-dose Covid-19 shot for emergency approval, clearing the way for a third vaccine to soon begin shipping in the world's hardest hit country. The committee's 22 members were convened by the Food and Drug Administration and included leading scientists as well as consumer and industry representatives. Although their recommendations aren't binding, they are usually followed. An emergency use authorization (EUA) will likely follow, probably in the coming days, making the J&J ...
AFP
Washington (AFP) - The Pfizer-BioNTech Covid-19 vaccine will reach hospitals and other sites across the United States by Monday morning, a top official said Saturday, ready to be injected into the arms of millions of the most vulnerable Americans. The shots will begin leaving the Pfizer factory in Kalamazoo, Michigan on Sunday, stored in boxes containing dry ice that are capable of staying at -70 degrees Celsius (-94 degrees Fahrenheit), the frigid temperature needed to preserve the drug. General Gus Perna, who is overseeing the massive logistical operation as part of the government's Operatio...
AFP
Washington (AFP) - The US Food and Drug Administration on Saturday defended itself from allegations of political pressure over the timing of its Pfizer-BioNTech Covid vaccine approval and provided new information on the risks to people with allergies. The FDA issued an emergency use authorization for the two-dose regimen late on Friday night following reports President Donald Trump had threatened to fire the head of the agency if he didn't act that day. Commissioner Stephen Hahn denied this had occurred, telling reporters: "The representations in the press that I was threatened to be fired if ...
AFP
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