Tag: New Product Approvals

FDA staff takes no position on Moderna’s COVID booster

Food and Drug Administration staffers didn’t take a firm stance on Moderna Inc.’s application for a booster dose, indicating there may not be sufficient data to support the extra dose. FDA staff, after reviewing a drugmaker’s application, often weigh whether it should be given a go-ahead. But they also didn’t take a position on Pfizer Inc.’s booster request, later granted. FDA staff […]

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Delta Air Lines to impose $200 monthly surcharge for unvaccinated employees in health care plan

Delta Air Lines Inc. DAL, +1.32% is stepping up efforts to get employees vaccinated against Covid-19, introducing measures including weekly testing requirements and a monthly health insurance surcharge for employees who don’t take the vaccines. The airline’s moves come amid growing pressure on companies to mandate vaccines for employees, particularly now that the Food and […]

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Drug-company-paid user fees under the microscope with beleaguered FDA in funding talks

Amid a firestorm over its approval of a new Alzheimer’s treatment, the Food and Drug Administration is holding closed-door meetings with companies it regulates — talks that critics say allow drug and device makers to exert outsize influence over the agency’s operations, threatening to erode public trust in the agency at a critical moment. The […]

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Full FDA approval of Pfizer’s and Moderna’s COVID-19 shots would reinvigorate the U.S. vaccination push — but it could still be months away

The “full” approval of Pfizer’s and Moderna’s COVID-19 vaccines will almost certainly boost sagging vaccination rates in the U.S., though the Food and Drug Administration’s decision might not come until the end of the year. The Pfizer Inc. PFE, +0.43% and Moderna Inc. MRNA, -0.34% vaccines, along with Johnson & Johnson’s JNJ, +1.82% COVID-19 shot, […]

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