Laurie McGinley, Carolyn Y. Johnson
Laurie McGinley, Carolyn Y. Johnson
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Experimental drug given to Trump to treat covid-19 wins FDA clearance

Experimental drug given to Trump to treat covid-19 wins FDA clearance

ADThe Food and Drug Administration on Saturday granted emergency authorization to the experimental antibody treatment given to President Trump last month when he developed covid-19, the disease caused by the novel .The drug, made by Regeneron Pharmaceuticals, is designed to prevent infected people from developing severe illness. Instead of waiting for the body to develop its own protective immune response, the drug imitates the body’s natural defenses. It is the second drug of this type — called a monoclonal antibody — to be cleared for treating covid-19. The FDA authorized Eli Lilly &...

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Laurie McGinley, Carolyn Y. Johnson
Nov 22
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FDA advisory committee debates safety and efficacy standards for a coronavirus vaccine

FDA advisory committee debates safety and efficacy standards for a coronavirus vaccine

Vaccine experts on Thursday rigorously debated the Food and Drug Administration’s planned standards for clearing a vaccine quickly for broad use, discussing what level of evidence would be sufficient to establish safety and effectiveness.The FDA advisory committee, in an all-day virtual meeting, did not consider any specific vaccine. The session served in large part as a venue for the agency to try to the public that any vaccine will be held to a high , not the relatively low bar used this year for emergency use authorization for treatments. The FDA said that though it probably will grant...

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Laurie McGinley, Carolyn Y. Johnson
Oct 22
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FDA poised to announce tougher standards for a covid-19 vaccine that make it unlikely one will be cleared by Election Day

FDA poised to announce tougher standards for a covid-19 vaccine that make it unlikely one will be cleared by Election Day

Please NoteThe Washington Post is providing this important information about the coronavirus for free. The Food and Drug Administration is expected to spell out a tough new standard for an emergency authorization of a coronavirus vaccine as soon as this week that will make it exceedingly difficult for any vaccine to be cleared before Election Day.The agency is issuing the guidance to boost transparency and public trust as it approaches the momentous decision of whether a prospective vaccine is safe and effective. Public health experts are increasingly worried that President Trump’s repeated...

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Laurie McGinley, Carolyn Y. Johnson
Sep 22
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Why the AstraZeneca trial for a coronavaccine was put on hold

Why the AstraZeneca trial for a coronavaccine was put on hold

Please NoteThe Washington Post is providing this important information about the coronavirus for free. Pharmaceutical giant AstraZeneca on Tuesday a late-stage trial of the experimental vaccine being developed with the against the novel coronavirus. Here are answers to some of the most common questions.The multinational company headquartered in Cambridge, England, paused global trials of its vaccine after a participant in its late-stage United Kingdom trial developed an unexplained illness that may or may not be related to the vaccination they received. The company described the temporary...

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Laurie McGinley, Carolyn Y. Johnson
Sep 9
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