The drama of the FDA’s approval of Biogen’s Aduhelm is far from over. But what happens next? Read More
Tag: fda
Controversial Alzheimer’s drug could cost US $334B—nearly half of DoD budget
Enlarge / Pedestrians walk past Biogen Inc. headquarters in Cambridge, Massachusetts, on Monday, June 7, 2021. Biogen Inc. shares soared after its controversial Alzheimer’s disease therapy was approved by US regulators. (credit: Getty | Bloomberg) Concern is mounting over the price of the controversial new Alzheimer’s drug Aduhelm. Advocates, lawmakers, and critics worry in particular […]
Google launches a new medical app—outside the United States
Enlarge (credit: Getty Images) Billions of times each year, people turn to Google’s web search box for help figuring out what’s wrong with their skin. Now, Google is preparing to launch an app that uses image recognition algorithms to provide more expert and personalized help. A brief demo at the company’s developer conference last month […]
FDA officials asked to step down after contentious Alzheimer’s drug approval
Enlarge / The Food and Drug Administration headquarters in White Oak, Maryland. (credit: Getty | Congressional Quarterly) A leading advocacy and watchdog group is calling for the ouster of three top officials at the Food and Drug Administration—including its acting commissioner—after the regulator issued a highly contentious approval last week of the unproven and now […]
After ruining 75M J&J doses, Emergent gets FDA clearance for 25M doses
Enlarge / The Emergent BioSolutions plant, a manufacturing partner for Johnson & Johnson’s COVID-19 vaccine, in Baltimore, Maryland, on April 9, 2021. (credit: Getty | Saul Loeb) The US Food and Drug Administration is making progress in its efforts to sort out the fiasco at Emergent BioSolutions’ Baltimore facility, which, at this point, has ruined […]
Three experts resign as FDA advisors over approval of Alzheimer’s drug
Enlarge / The Food and Drug Administration headquarters in White Oak, Maryland. (credit: 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 […]
A “disgraceful decision:” Researchers blast FDA for approving Alzheimer’s drug
Enlarge (credit: 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 […]
CDC loosened mask guidance to encourage vaccination—it failed spectacularly
Enlarge / A thrown-away surgical mask lays on the ground. (credit: Getty | David Gannon) The Centers for Disease Control and Prevention stunned health officials and experts 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 […]
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. (credit: 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 […]
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. (credit: 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 […]