Laurie McGinley

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FDA to meet with outside advisers on coronavirus booster shots Sept. 17. That’s just days before the shots are expected to become available.

The session, which will be public, could add clarity and transparency to a decision-making process that some people have criticized as confusing.

FDA facing demands to snuff out Juul’s e-cigarettes

The agency is supposed to decide by Sept. 9 whether the embattled company — and many other e-cigarette manufacturers — will be allowed to keep selling their products and, if so, under what conditions.

Study suggests nearly half kids with covid-19 often have no symptoms

Asymptomatic infections were more common in kids than in the elderly or in people without preexisting medical conditions, researchers say.

Biden administration to announce most Americans will need coronavirus booster shots

The actual administration of the boosters is not expected until mid- or late September.

FDA authorizes extra vaccine doses for immunocompromised patients to bolster protection against the coronavirus

The action by the Food and Drug Administration means additional shots could be available for the immunocompromised as soon as this weekend.

Coronavirus booster shots for the immunocompromised expected to be authorized soon

The Biden administration accelerates efforts to shield some of the most vulnerable Americans from the highly contagious delta variant.

Q&A: When might the coronavirus vaccines get full approval?

‘We will work towards getting this across the finish line as rapidly as possible,’ vows the agency’s top vaccine official, but declines to offer timetable.

FDA vows ‘all hands on deck’ effort to get Pfizer coronavirus vaccine full approval as quickly as possible

Some agency officials have suggested it could be a matter of weeks, not months, when a coronavirus vaccine receives full approval.

FDA asks Pfizer, Moderna to test their vaccines in more children to help rule out safety issues

The changes to ongoing trials run by Moderna and Pfizer and its German partner BioNTech could delay the availability of the vaccine to children between the ages of 5 and 11 beyond the hoped-for timeline of early fall, although it is unclear by how much.

FDA adds new warning on Johnson & Johnson vaccine related to rare autoimmune disorder

About 100 preliminary reports of Guillain-Barré have been detected after 12.8 million doses of Johnson & Johnson vaccine were administered, the Centers for Disease Control and Prevention said in a statement.