Pfizer and BioNTech will soon ask the Food and Drug Administration for emergency authorization of Covid booster doses for that age group, the companies said.
Tag: Food and Drug Administration
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McKinsey Opened a Door in Its Firewall Between Pharma Clients and Regulators
The firm let consultants advise both drugmakers and their government overseers, internal records show. “Who we know and what we know” was part of their pitch.
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New Drug Slashed Deaths Among Patients With Severe Covid, Maker Claims
A late-stage trial was halted after strong early results, according to the company, but outside scientists have not yet seen the data.
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Medicare Officially Limits Coverage of Aduhelm to Patients in Clinical Trials
Officials cited data showing the new Alzheimer’s drug has serious safety risks and may not help patients.
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F.D.A. Panel Weighs Challenges of Revamping Covid Vaccines for Fall
A meeting of the committee underscored how many uncertainties lie ahead, including whether a vaccine that works better against variants can be ready by fall.