FDA Panel Supports Authorizing Moderna Vaccine for Children 6 to 17

UpdateOn June 17, the FDA authorized the Moderna COVID-19 vaccine for children and adolescents aged 6 to 17. Update On June 17, the FDA authorized the Moderna COVID-19 vaccine for children and adolescents aged 6 to 17. Key TakeawaysAn FDA panel voted to authorize Moderna’s two-dose COVID-19 vaccine for ages 6 to 17.12- to 17-year-olds will receive the same dosage as adults, while 6- to 11-year-olds will receive a half dose....

January 17, 2025 · 6 min · 1274 words · David Suarez

FDA Permanently Allows Mail Order Abortion Pills

Key TakeawaysThe FDA is permanently removing an in-person dispensing requirement for the abortion pill.Experts say this is a big step for abortion access and a win for pro-choice advocates.Despite the FDA decision, some states still prohibit mail orders or telemedicine visits for the abortion pill. Key Takeaways The FDA is permanently removing an in-person dispensing requirement for the abortion pill.Experts say this is a big step for abortion access and a win for pro-choice advocates....

January 17, 2025 · 6 min · 1070 words · Lynn Alexander

FDA Recalls Insulin Pump App After 200+ Injuries

Key Takeaways The Food and Drug Administration (FDA) has issued a correction recall for an Apple iOS app that is used with an insulin pump. The app has caused at least 224 injuries after draining the pump batteries and causing them to shut off early. This is a Class I recall, which is “the most serious type of recall,” the FDA said in astatement. “Use of these devices may cause serious injuries or death....

January 17, 2025 · 3 min · 617 words · Sonya Smith

FDA Recommends Booster Shots for Omicron Subvariants

Key TakeawaysThe FDA recently voted in favor of Omicron-adapted booster shots to have stronger immunity against the circulating and emerging variants.Pfizer and Moderna have developed different kinds of Omicron-adapted booster candidates that elicit a higher immune response against Omicron subvariants.The reformulated boosters may not be available until the fall.In anticipation of another COVID-19 surge, the Food and Drug Administration (FDA) recently recommended vaccine makers to update their booster shots to include components of the Omicron subvariants BA....

January 17, 2025 · 7 min · 1458 words · Joshua Ingram

FDA Revokes Authorization for the Only Remaining COVID-19 Monoclonal Antibody Treatment

Key TakeawaysThe monoclonal antibody bebtelovimab is no longer authorized as a treatment for COVID-19, the FDA said.Bebtelovimab does not appear to hold up against the dominant Omicron subvariants BQ.1 and BQ.1.1.The FDA decision removes the last available monoclonal antibody treatment for COVID-19 from the market, leaving immunocompromised individuals more vulnerable heading into the winter season. Key Takeaways The monoclonal antibody bebtelovimab is no longer authorized as a treatment for COVID-19, the FDA said....

January 17, 2025 · 5 min · 985 words · Kendra Hall

FDA Says Popular Prescription Lice Treatment Can Be Sold Over-the-Counter

Key TakeawaysSklice, a lice treatment that was only available with a prescription, will now be sold over-the-counter.Only one dose is needed to kill live lice and application time is 10 minutes. Combing is not needed afterward.Dermatologists confirm that Sklice is effective in treating head lice. Key Takeaways Sklice, a lice treatment that was only available with a prescription, will now be sold over-the-counter.Only one dose is needed to kill live lice and application time is 10 minutes....

January 17, 2025 · 10 min · 1966 words · Rodney Pierce

FDA Scales Back Use of 2 Monoclonal Antibody Treatments for COVID-19

Key TakeawaysThe FDA is advising against use of monoclonal antibodies from Eli Lilly and Regeneron to treat the Omicron COVID-19 variant because they are not very effective against this strain of the virus.There are at least four other treatments thatareeffective against the virus.Your best protection against COVID-19 is vaccination and a booster dose. Key Takeaways The FDA is advising against use of monoclonal antibodies from Eli Lilly and Regeneron to treat the Omicron COVID-19 variant because they are not very effective against this strain of the virus....

January 17, 2025 · 4 min · 775 words · Beverly Morris

FDA Scales Back Use of Johnson & Johnson COVID Vaccine

Key TakeawaysThe FDA now recommends Pfizer and Moderna mRNA COVID-19 vaccines over the Johnson & Johnson shot, following concerns about blood clots.The J&J vaccine is linked to a rare but serious blood clotting problem called thrombosis with thrombocytopenia syndrome (TTS).Protection from the Johnson & Johnson vaccine is still better than not getting a vaccine at all. Key Takeaways The FDA now recommends Pfizer and Moderna mRNA COVID-19 vaccines over the Johnson & Johnson shot, following concerns about blood clots....

January 17, 2025 · 7 min · 1396 words · Aaron Schneider

FDA Stalls In Decision to Completely Ban Vapes

Key TakeawaysThe FDA denied marketing applications for millions of vaping products because they lacked sufficient evidence on the benefits for adult smokers.The FDA has yet to make a decision on products from dominant e-cigarette companies like Juul, Vuse, and NJOY.Harm reduction advocates say that e-cigarettes should remain on the market to encourage smoking cessation and reduce black market sales, but critics are worried about use among youth and potential health risks....

January 17, 2025 · 6 min · 1103 words · Samuel Russo

FDA Temporarily Allows Abortion Pills to Be Shipped Through Mail

Key TakeawaysAn FDA requirement that drugs needed to terminate an early pregnancy be administered in a medical clinic was temporarily lifted for the duration of the pandemic.Despite the FDA’s temporary lift, access toabortion pillsvia telemedicine is controlled on the state level.According to the Guttmacher Institute, 19 states prohibit the use of telemedicine to prescribe medication to terminate a pregnancy. Key Takeaways An FDA requirement that drugs needed to terminate an early pregnancy be administered in a medical clinic was temporarily lifted for the duration of the pandemic....

January 17, 2025 · 6 min · 1256 words · Dale Berry

FDA to Allow Pharmacies to Dispense Abortion Pills

Key Takeaways Under the new rules, certified pharmacies can dispense Mifeprex (mifepristone) and its approved generic—the first of the two drugs in the medication abortion regimen—to people who have a prescription from a certified prescriber. The second drug, misoprostol, is unrestricted and is used to treat other conditions such as stomach ulcers. The decision could allow easier access to medication abortions, but retail pharmacies may still have to comply with the laws in states where abortion pills are restricted or banned....

January 17, 2025 · 3 min · 629 words · Karen Knox

FDA Updates Side Effects For 3 Rheumatoid Arthritis Drugs

Key Takeaways Xeljanz suppresses the immune system and is approved to treat three autoimmune diseases:rheumatoid arthritis,psoriatic arthritis, andulcerative colitis. The study only included patients with rheumatoid arthritis. Rheumatoid Arthritis Treatment: A Guide to Symptom Management The FDA approved Xeljanz to treat rheumatoid arthritis in 2012, “but had concerns enough to not give it a blanket approval, but to say we want to see some further evidence,” Steven Ytterberg, MD, lead study author, told Verywell....

January 17, 2025 · 6 min · 1099 words · Katrina Hobbs

FDA Warns Certain Arthritis and Pain Products May Have Hidden Ingredients

Key Takeaways The Food and Drug Administration (FDA) is warning consumers that some arthritis and pain management products contain hidden ingredients that could be dangerous. Through extensive testing over 10 years, the FDA found that some arthritis and pain management products contain active drug ingredients and components commonly found in prescription drugs, which could come with significant health risks for people who use these products. “These products may cause potentially serious side effects and may interact with medications or dietary supplements a consumer is taking,” the agency said in astatement....

January 17, 2025 · 7 min · 1413 words · Benjamin Thomas