FDA Authorizes Another COVID Booster for Older Adults
The current and near-future plans for COVID-19 vaccines will revolve around Pfizer-BioNTech’s and Moderna’s shots.
FDA authorizes AstraZeneca COVID prevention drug for immunocompromised people
According to the FDA, it may be effective for six months. (Eli Lilly’s treatmentwas authorized last week for children under 12 who are at high risk.) AstraZeneca said its treatmentreduced riskof hospitalization and death by 83%. COVID-19 treatment pills made byMerckandPfizerare expected to be available soon to high-risk adults.
FDA Authorizes Breath Test for COVID-19 Diagnosis
The US Food and Drug Administration on Thursday issued emergency use authorization for aCOVID-19 diagnostic test using breath samples. The InspectIR COVID-19 Breathalyzer test detects five chemical compounds found in the exhaled breath of COVID patients. Each instrument can be used to test 160 samples per day. It was 99.3% accurate when correctly identifying negative samples. Positive results should be confirmed with molecular tests, the FDA said.
FDA Authorizes First At-Home COVID and Flu Test, but You Can't Buy One Yet
TheA and B strains of the fluare responsible for the flu season every year. Lucira’s bankruptcy was previously reported bySTAT newsand other media. While symptoms may be similar in many people, flu and COVID-19 are different viruses with different treatments. Getting treated early for either virusreduces someone’s risk of getting severely sick. Here’s What Will Happen to Health Care
FDA authorizes Merck pill molnupiravir to treat COVID-19
Pregnant women should also avoid the drug, due to potential fetal harm. Pfizer’s pill, by contrast, was cleared for use by those aged 12 or older. The EUA is different from the FDA’s regular approval.
FDA authorizes Pfizer pill to treat COVID-19
Pfizer COVID-19 pillshave now been authorized by the US Food and Drug Administration to treatCOVID-19patients. The FDA made the decision togive emergency use authorization to Paxlovidon Wednesday.
FDA Ban on Juul E-Cigarettes Gets Put On Hold for Now
On Thursday, theFDA ordered Juul to stop sellingand distributing its vape pens and flavored pods. E-cigarettes were initiallymarketed to former smokersas a way of helping them avoid the harmful effects of real cigarettes. They work by converting liquidnicotine into vapor. Each year, 480,000 peopledie from diseases attributed to smoking, according to the FDA. Juul didn’t respond to a request for comment. The FDA said it doesn’t comment on possible, pending or ongoing litigation....
FDA Clears Abbott's Freestyle Libre 3 Glucose Sensor
It will become available later in 2022. The Freestyle Libre 3 isnot eligible for Medicare reimbursement at the moment. Abbott has been in the spotlight for its role in the ongoingbaby formula shortagein the US. In February, Abbottrecalleda number of batches of itsSimilac, Alimentum and EleCare infant formula brandsafter reports of infections. Abbott also ceased production at the Michigan factory where the possibly contaminated formula was produced. Read more:Best Continuous Glucose Monitors for 2022
FDA Clears New Continuous Glucose Monitor From Dexcom
The G7 will be available in the US in early 2023. Read more:Wearable Sensors That Track Glucose, Ketones and Alcohol Levels Are the Future
FDA clears ScanWatch, a hybrid smartwatch that monitors ECG and blood oxygen levels
Your Sp02 measurement tells you yourblood oxygen level. The watch has also been used in a study in Germany to monitor COVID-19 patients, the company says. COVID-19 can cause respiratory problems as well as damage to the heart. ScanWatch is water-resistantup to 5 atmospheresand has a battery life of up to 30 days, per Withings.
FDA Looking Into Claims That Lucky Charms Are Making People Sick
The claims have created enough attention to result in a recent punchline on Saturday Night Live’sWeekend Update. A spokesperson with the US Food and Drug Administration said the agency is investigating the complaints. AsInsiderreported, illnesses that can cause severe vomiting and diarrhea such as thenorovirusmay also be circulating in the US.
FDA Might Authorize First Over-the-Counter Birth Control Pill
Birth control pills require a prescription in the US, but that might be on track to change. Oral contraceptives, another term for birth control pills, are highly effective at preventing pregnancy. They’re also used to manage some medical conditions includingendometriosis. Mini pills like Opill contain just progestin, instead of the more-commoncombination pillsthat have estrogen and progestin. HRA Pharma officials expect a decision from the FDA within 10 months, according to the Times....
FDA Panel Endorses Moderna and Pfizer COVID Vaccines for Kids as Young as 6 Months
Pfizer’s vaccine is slightly different. The Vaccines and Related Biological Products Advisory Committee approved each recommendation on a 21-0 vote. On Tuesday, the FDApanel unanimously endorsedthat Moderna’s vaccine should be approved for kids ages 6 through 17.
