FDA

Millions of Americans will be able to buy hearing aids without a prescription later this fall, under a long-awaited rule finalized Tuesday. The Food and Drug Administration said the new regulation cuts red tape by creating a new class of hearing aids that don’t require a medical exam, a prescription and other specialty evaluations. Instead the devices will be...

New U.S. recommendations call for three home tests for people exposed to COVID-19 to improve accuracy.

The head of the Food and Drug Administration has asked for a review of the agency’s food and tobacco programs following months of criticism over their handling of the baby formula shortage and e-cigarette reviews.

BrandStorm announced a voluntary recall of its Natierra Organic Freeze-Dried Blueberries due to possible unhealthy levels of lead. Check your pantry for lot numbers 2021363-1 (UPC 812907011160) and 2022026-1 (UPC 812907011160).

Mars, Incorporated is being sued for its use of titanium dioxide (TiO2) in Skittles.

U.S. officials say thousands more doses of the monkeypox vaccine could soon begin shipping from Denmark after the FDA completed a required inspection of the overseas plant where the two-dose shots are manufactured.

Stormberg Foods is recalling several brands of its dog treats products due to concerns of salmonella contamination, the Food and Drug Administration announced Tuesday.

A drug company is seeking U.S. approval for the first-ever birth control pill that women could buy without a prescription

The move is part of an effort to diversify the industry and formula sources after the closure of the country’s largest domestic plant over safety concerns earlier this year led to nationwide shortages and widespread outrage.

The Pfizer pill, Paxlovid, is intended for people with COVID-19 who are more likely to become seriously ill. Previously only doctors could prescribe the drug

The Food and Drug Administration has issued an administrative stay on the order it issued last month for vaping company Juul to pull its electronic cigarettes from the market. The agency says the stay temporarily suspends the marketing denial order while it conducts further review, but does not rescind it.

The FDA said risks of baby neck floats “include death due to drowning and suffocation, strain, and injury to a baby’s neck.”

The Food and Drug Administration rejected Juul’s application to sell its e-cigarettes in the U.S.

The FDA authorized the first COVID-19 vaccination for children as young as six months on Friday. A panel of CDC advisors will vote Saturday, meaning shots for infants and preschoolers could be available as early as next week.

U.S. regulators on Friday authorized the first COVID-19 shots for infants and preschoolers, paving the way for vaccinations to begin next week.

COVID-19 shots for U.S. infants, toddlers and preschoolers moved a step closer Wednesday. The Food and Drug Administration’s vaccine advisers gave a thumbs-up to vaccines from Moderna and Pfizer for children under 5. NBC10’s Leah Uko gets reactions from parents.

The FDA must still decide whether to take the recommendations and approve the COVID-19 vaccine for kids between six months and 5 years old.

COVID-19 shots for U.S. infants, toddlers and preschoolers moved a step closer Wednesday.

A government advisory panel has endorsed a second brand of COVID-19 vaccine for school-age children and teens. The expert panel agreed Tuesday that the vaccine made by Moderna is safe and effective enough to give to U.S. kids ages 6 to 17. A vaccine made by Pfizer has been available since last year for those ages. The Food and Drug...

An analysis from the U.S. Food and Drug Administration states that kid-sized doses of Pfizer’s COVID-19 vaccine appears safe and effective for children under five, which would be a huge step towards vaccinating the nation’s youngest children who were previously unprotected.