Laurie McGinley

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Pfizer and BioNTech seek authorization of second coronavirus booster shot for people 65 and older

The application comes as federal officials and the public health community debate whether fourth shots will be needed for the general public.

Congress moves to give FDA new powers over synthetic nicotine products including a youth favorite — Puff Bar e-cigarettes

Lawmakers tout a provision that would make laboratory-made nicotine subject to federal regulation.

Califf narrowly confirmed for FDA commissioner, providing beleaguered agency with its first permanent chief in 13 months

Robert M. Califf, a cardiologist, led the Food and Drug Administration at the end of the Obama administration.

Coronavirus vaccine for young children further delayed as FDA reverses course, says it will wait for data on three doses

The delay means it could be mid-April at the earliest before shots are available.

Biden relaunches ‘cancer moonshot,’ aiming to reduce death rate by 50 percent in 25 years

The president’s new initiative promises improvements in prevention, detection and treatment of malignancies but does not contain new money for the effort.

Pfizer-BioNTech coronavirus vaccine for children under 5 could be available by the end of February, people with knowledge say

The shot would be the first for children 6 months to 5 years old.

FDA ends for now use of two monoclonal antibodies, spurring a halt in federal shipments of the covid-19 treatments

The therapies by Regeneron and Eli Lilly are not effective against the omicron variant, officials said.

At the besieged FDA, ‘it never stops!’ as decisions loom on boosters, pediatric shots and more

Internal conflicts over whether — and when — to approve boosters are part of a tumultuous season with few parallels for the federal agency.

FDA delays decision on whether Juul e-cigarettes will be banned

The agency barred sales of many other flavored vaping products but said it is still reviewing companies with the biggest market share.

House committees step up investigation into FDA approval of controversial Alzheimer’s drug

The agency’s accelerated approval of the medication was welcomed by some advocates and doctors as a step forward in treating the devastating disease but strongly criticized by many experts who say the medication hasn’t been shown to be effective.