Tag: FDA Food and Drug Administration

FDA authorizes Pfizer COVID-19 boosters for 12- to 15-year olds

On Monday, the Food and Drug Administration approved Pfizer COVID-19 boosters for 12- to 15-year-olds as schools reopen after the holiday break amid the omicron variant surge. In a release, the FDA also said it has amended the emergency use authorization for the Pfizer vaccine for the coronavirus to also shorten the time between the […]

J&J’s Booster shown to be especially effective against Hospitalization due to Omicron Variant

Two doses of Johnson & Johnson’s Covid-19 vaccine provided up to 85 percent protection against hospitalization from the Omicron variant, researchers in South Africa have reported. The study from the South African Medical Research Council evaluated a second booster shot in 69,092 health care workers from November 15 to December 20. Researchers observed that effectiveness […]

FDA says Rapid COVID-19 Antigen Tests may be Less Sensitive in detecting the Omicron Variant

NBC News reports that the Food and Drug Administration’s preliminary research shows some rapid antigen tests may be less sensitive at detecting the highly contagious omicron variant of the coronavirus. Case numbers are surging across the country, prompting high demand for at-home rapid testing. Antigen tests can be done at home, with results in minutes, while […]

FDA Approves First Injectable HIV Prevention Drug

Officials at the Food and Drug Administration (FDA) have announced the approval of the first injectable, HIV preexposure prophylaxis (PrEP) drug. The drug is called Apretude and it’s taken every 2 months to reduce the chance of sexually acquired HIV. “Today’s approval adds an important tool in the effort to end the HIV epidemic by […]

Dole Recalls Packaged Salads Due to Possible Listeria Contamination

Dole Fresh Vegetables has voluntarily recalled all Dole-branded and private label packaged salads processed at its Bessemer City, N.C. and Yuma, Ariz. processing facilities due to a possible Listeria contamination. The recall affects dozens of Dole products, including shredded carrots, coleslaw, and various salad kits, sold at Kroger, Lidl, and additional retailers nationwide. This massive […]

FDA Allows Abortion Pill to Stay Available by Mail

Access to abortion pills by mail was made permanent by the U.S. Food and Drug Administration last Thursday. Health Day News reports that Patients will be able to have a telemedicine appointment with a provider who can prescribe the pills and send them to the patient by mail, the FDA said. Abortion pills are approved […]

New FDA-Approved Eyedrops Could Replace your Reading Glasses

WebMD reports that new FDA-approved eyedrop medicine could replace reading glasses for millions of Americans who have age-related blurry vision. The product, called Vuity, was approved by the FDA in October and went on the market last week. The new medicine begins working in about 15 minutes and provides sharper vision for 6 to 10 hours. Vuity is […]

The Withings ScanWatch with EKG is finally available in the US

After almost two years, the Withings ScanWatch is now available to purchase in the US after its announcement back at the beginning of 2020. The ScanWatch was waiting for clearance from the Food and Drug Administration, which it had received in October for its EKG and blood oxygen measurement features. Unlike its competitors Apple Watch and Fitbit, both […]

FDA Authorizes a Virtual Reality treatment for Chronic Back Pain

Last week, the Food and Drug Administration authorized a virtual reality system as a prescription treatment for chronic back pain. The therapy, called EaseVRx, joins the short list of digital therapeutics cleared by the agency over the past few years. EaseVRx includes a VR headset and a device that amplifies the sound of the user’s breath to […]

FDA clears Pfizer and Moderna COVID-19 boosters for all US adults

The Food and Drug Administration has just opened booster shots for the Pfizer / BioNTech and Moderna COVID-19 vaccine to all adults, expanding eligibility outside of the initial, vulnerable groups they were cleared for earlier this fall. Just over 16 percent of people in the United States who had an initial vaccine series have already received a booster shot. This expanded eligibility should […]