FDA Authorizes Monoclonal Antibody COVID Treatment for All High-Risk Children

Key TakeawaysThe Food and Drug Administration (FDA) has extended its emergency use authorization (EUA) for the combination of twomonoclonal antibody drugsto treat COVID-19 in all children, including newborns.The combination of drugs—bamlanivimab and etesevimab—is authorized to treat mild-to-moderate COVID in children who are at high risk of becoming severely sick.The combination of drugs can also be used as a preventive treatment in children who have been exposed to COVID and are at high risk for developing severe illness....

January 17, 2025 · 10 min · 2056 words · Sara Murray

FDA Authorizes New Drug for Emergency Use on Hospitalized COVID-19 Patients

Key TakeawaysFDA granted emergency use authorization for Actemra, an anti-inflammatory drug, to treat hospitalized COVID-19 patients.The drug has been shown to reduce the risk of COVID-19 related death, need for ventilation, and length of hospital stay.Unvaccinated people are still among the most vulnerable to COVID-19 infection. Key Takeaways FDA granted emergency use authorization for Actemra, an anti-inflammatory drug, to treat hospitalized COVID-19 patients.The drug has been shown to reduce the risk of COVID-19 related death, need for ventilation, and length of hospital stay....

January 17, 2025 · 4 min · 693 words · Michelle Miles

FDA Authorizes Pfizer As First COVID-19 Vaccine

Key Takeaways The news follows a much-anticipated public hearing on Thursday, during which an advisory panel to the FDA voted 17-4 in favor of the Pfizer vaccine’s authorization, with one abstention. Pfizer presented data from clinical trials involving 43,000 adult participants.Earlier this week, the FDA shared some of that data, including the fact that 95% of people in the clinical trial who received the vaccine did not go on to develop COVID-19....

January 17, 2025 · 5 min · 977 words · Christine Carpenter

FDA Authorizes Pfizer Booster for Seniors and High Risk Groups. What's Next?

Key TakeawaysFDA authorized Pfizer’s COVID-19 booster shots for people aged above 65 and high risk groups.CDC still has to define high risk groups and decide on whether people should mix and match boosters.A CDC panel said that there’s insufficient data on Moderna and Johnson & Johnson boosters, as well as the Pfizer booster’s efficacy in people younger than 18. Key Takeaways FDA authorized Pfizer’s COVID-19 booster shots for people aged above 65 and high risk groups....

January 17, 2025 · 6 min · 1234 words · Dominique Young

FDA Authorizes Protective Collar for Athletes at Risk for Brain Injuries

Key TakewaysThe U.S. Food and Drug Administration authorized the marketing of the Q-Collar, a jugular vein compression collar, meant to protect the brain from repeat impact.The Q-Collar is not designed to prevent concussions or other serious head injuries.Even if a person is wearing additional protective gear like the Q-Collar, they should still focus on playing safely. Key Takeways The U.S. Food and Drug Administration authorized the marketing of the Q-Collar, a jugular vein compression collar, meant to protect the brain from repeat impact....

January 17, 2025 · 6 min · 1221 words · Cassandra Sanchez

FDA Authorizes the First COVID-19 At-Home Test: What You Need to Know

Key TakeawaysThe FDA authorized the first at-home test kit for COVID-19.Results are available in as little as 30 minutes.Experts say it’s a good next step in expanding testing. Key Takeaways The FDA authorized the first at-home test kit for COVID-19.Results are available in as little as 30 minutes.Experts say it’s a good next step in expanding testing. The Food and Drug Administration (FDA) granted an emergency use authorization this week for the first self-administered at-home test kit for COVID-19....

January 17, 2025 · 6 min · 1272 words · Richard Berry

FDA Authorizes Updated Moderna and Pfizer Booster Shots

Key TakeawaysFederal regulators authorized Pfizer’s and Moderna’s reformulated booster vaccines.The updated booster shots can protect against the original COVID-19 strain as well as the BA.4 and BA.5 Omicron variants.The shots could be doled out shortly after Labor Day if the CDC director signs off on the recommendation. Key Takeaways Federal regulators authorized Pfizer’s and Moderna’s reformulated booster vaccines.The updated booster shots can protect against the original COVID-19 strain as well as the BA....

January 17, 2025 · 4 min · 794 words · Tracy Lee

FDA Authorizes Updated Novavax COVID-19 Vaccine

Key TakeawaysNovavax’s updated COVID-19 vaccine is now authorized for U.S. teens and adults.The new version is designed to protect against currently circulating COVID-19 variants.The protein-based vaccine is the only immunization option that does not use mRNA technology. Key Takeaways Novavax’s updated COVID-19 vaccine is now authorized for U.S. teens and adults.The new version is designed to protect against currently circulating COVID-19 variants.The protein-based vaccine is the only immunization option that does not use mRNA technology....

January 17, 2025 · 4 min · 696 words · Jaclyn Johnson

FDA Clears a New Patch for Excessive Armpit Sweating

Key Takeaways The Food and Drug Administration (FDA) cleared a brand new patch that treatsexcessive armpit sweating, and it just might be the secret to saving your white T-shirts. The new treatment, called the Brella SweatControl Patch, is a single-use disposable underarm patch that can reduce the symptoms ofhyperhidrosis—excessive sweating that’s not always related to heat or exercise. One application can last up to four months. What Are the Hyperhidrosis Treatment Options?...

January 17, 2025 · 6 min · 1106 words · Elizabeth Cooper

FDA Clears an Apple Watch Feature That Helps Monitor AFib

Key Takeaways Apple just made it easier to monitoratrial fibrillation (AFib), an irregular heart rhythm that increases the risk of stroke, with an Apple Watch feature. “While there is still research work to be done to best understand how to use these devices to monitor AF, the data to date has been helpful in showing us that the devices can detect AF in both symptomatic and asymptomatic individuals,” saidRobert Harrington, MD, an interventional cardiologist and the chairman of the department of medicine at Stanford University....

January 17, 2025 · 4 min · 827 words · Michael Waller

FDA Clears Breast Cancer Vaccine For Clinical Trials

Key Takeaways On December 21, the Food and Drug Administration (FDA) approved an investigational drug application for a triple-negative breast cancer vaccine that could reduce the incidence of advanced disease. The brainchild of Vincent Tuohy, PhD, a researcher in the department of inflammation and immunity at the Cleveland Clinic’s Lerner Research Institute, the vaccine has been preemptively licensed to the biotechnology company Anixa Biosciences. Triple-negative breast cancer—so named because it does not produce receptors for the hormones estrogen and progesterone and only produces HER2, the receptor for the protein human epidermal growth factor, in small amounts—accounts for about 10-15% of all breast cancers, making it one of the disease’s rarer incarnations....

January 17, 2025 · 6 min · 1179 words · Peter Harris

FDA Clears Diabetes Medication for Obesity in Adolescents

Key TakeawaysThe U.S. Food and Drug Administration has approved liraglutide for use in adolescents over the age of 12 who are living with obesity.It’s the first time in several years a new medication has been approved for use in children.The medication is used to treat diabetes, and works via a different pathway than the two other medications available to adolescents to treat obesity. Key Takeaways The U.S. Food and Drug Administration has approved liraglutide for use in adolescents over the age of 12 who are living with obesity....

January 17, 2025 · 6 min · 1145 words · Nancy Hernandez

FDA Clears the First Implantable Continuous Glucose Monitor That Can Last a Year

Key Takeaways The Food and Drug Administration (FDA) hasclearedSenseonics’ Eversense 365, the latest implantablecontinuous glucose monitoring (CGM)system for adults with diabetes that can last up to a year. The previous monitor, Eversense E3, couldlast up to six months without replacement. The Eversense 365 implant features a small sensor, about the size of a grain of rice, that is inserted under the skin of the upper arm. The sensor sends blood sugar readings every five minutes to a mobile app, allowing patients to monitor their levels in real-time....

January 17, 2025 · 5 min · 1032 words · Tiffany Romero