fda

Three experts resign as FDA advisors over approval of Alzheimer’s drug

Enlarge / The Food and Drug Administration headquarters in White Oak, Maryland. Getty | Congressional Quarterly Fallout continues from the Food and Drug Administration’s contentious decision this week to approve Biogen’s Alzheimer’s drug Aduhelm (aducanumab) despite a lack of efficacy data. Three experts who sat on an advisory committee for the FDA have now resigned …

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A “disgraceful decision:” Researchers blast FDA for approving Alzheimer’s drug

Enlarge Getty | Congressional Quarterly The US Food and Drug Administration on Monday approved the antibody drug Aduhelm (generic name aducanumab) to treat Alzheimer’s disease. Aduhelm is the first new Alzheimer’s drug to earn FDA approval since 2003. It’s also the first drug to target a theoretical cause of the irreversible neurodegenerative disease—clumps of beta-amyloid …

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CDC loosened mask guidance to encourage vaccination—it failed spectacularly

Enlarge / A thrown-away surgical mask lays on the ground. Getty | David Gannon The Centers for Disease Control and Prevention stunned health officials and experts on May 13 with the abrupt announcement that people fully vaccinated against COVID-19 could forgo masking in most settings—indoor, outdoor, uncrowded, and crowded alike. The guidance was a stark …

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Moderna’s data in kids ages 12-17 “consistent with a vaccine efficacy of 100%”

Enlarge / A vial of the current Moderna COVID-19 vaccine. Getty | Ivan Romano Moderna’s COVID-19 vaccine appears safe and highly effective in adolescents ages 12 to 17, according to the top-line results of a small clinical trial the company announced Tuesday. The company plans to submit the trial data to the US Food and …

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Pfizer’s COVID vaccine can stay in normal fridge for up to a month, FDA says

Enlarge / A pharmacist holding a vial of the undiluted Pfizer-BioNTech vaccine for COVID-19. Getty | JEAN-FRANCOIS MONIER The US Food and Drug Administration on Wednesday announced a big change in the way doses of Pfizer-BioNTech’s COVID-19 vaccine can be handled. From now on, undiluted vials of the mRNA vaccine can stay at normal refrigerator …

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Before ruining millions of vaccines, Emergent failed inspections, raked in cash

Enlarge / Robert Kramer, President and Chief Executive Officer of Emergent BioSolutions, speaks via videoconference during a House Select Subcommittee on the Coronavirus Crisis hearing in the Rayburn House Office Building on Capitol Hill on May 19, 2021, in Washington, DC. Stefani Reynolds-Pool / Getty Images When contract-manufacturer Emergent BioSolutions contaminated at least 15 million …

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CDC advisory committee recommends COVID vaccine for 12- to 15-year-olds

Enlarge / With new data, we’re able to expand vaccinations to ever-younger populations. Roberto Jimenez Mejias / Getty Images Update, 10:00pm EDT: CDC Director Rochelle Walensky has followed the Advisory Committee’s advice. In a statement released this evening, she said, “CDC now recommends that this vaccine be used among [the 12-15 year old] population, and providers …

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FDA authorizes Pfizer’s COVID-19 vaccine for 12- to 15-year-olds

Enlarge / An illustration picture shows vials with COVID-19 Vaccine stickers attached, with the logo of US pharmaceutical company Pfizer, on November 17, 2020. Getty | JUSTIN TALLIS The US Food and Drug Administration has authorized the use of the Pfizer-BioNTech COVID-19 vaccine in adolescents between the ages of 12 to 15, the agency announced …

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Biden shifts strategy as national vaccination rate continues to slow

Enlarge / US President Joe Biden speaks in the State Dining Room of the White House in Washington, DC, on Tuesday, May 4, 2021. Getty | Bloomberg By July 4—two months from today—the Biden administration wants to have 70 percent of American adults vaccinated with at least one dose of a COVID-19 vaccine and 160 …

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FDA reportedly plans to authorize Pfizer’s COVID vaccine for teens 12-15 in days

Enlarge / Vials with COVID-19 Vaccine labels showing logos of pharmaceutical company Pfizer and German biotechnology company BioNTech. Getty | Photonews The Food and Drug Administration is planning to authorize the use of Pfizer-BioNTech’s COVID-19 vaccine in adolescents 12 to 15 years old later this week or early next week, according to a report by …

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