Key TakeawaysThe FDA has cleared a prescription mobile app to treat major depressive disorder.The app, called Rejoyn, is intended to be used as an adjunct treatment along with antidepressants and talk therapy.Mental health experts say it could be worth trying since most people are already using their phones frequently. Key Takeaways The FDA has cleared a prescription mobile app to treat major depressive disorder.The app, called Rejoyn, is intended to be used as an adjunct treatment along with antidepressants and talk therapy....

Key TakeawaysPfizer has requested permission from the Food and Drug Administration (FDA) to give a modified version of its COVID-19 vaccine to children ages 5 to 11.The “kid-sized” version of the vaccine provides a smaller dose than the current dose given to people ages 12 and older.In clinical trials with over 2,000 children, Pfizer’s vaccine was shown to be effective and safe, with only mild side effects reported (such as redness and pain at the injection site)....

UPDATEOn Friday, January 8 the World Health Organization (WHO) approved delaying the times between doses of Pfizer and BioNTech’s COVID-19 vaccine. They published guidance stating that the interval between both doses can be extended up to 42 days (6 weeks), based on clinical trial data. The recommended interval is still 21 to 28 days, and the U.S. has not yet announced plans to extend the time between doses. UPDATE On Friday, January 8 the World Health Organization (WHO) approved delaying the times between doses of Pfizer and BioNTech’s COVID-19 vaccine....

Key TakeawaysThe FDA is delaying its meeting to review the safety and effectiveness of the Pfizer COVID-19 vaccine for kids under 5.Pfizer is gathering more data and expects to submit it to the FDA for review in the next month or two.Experts say while this is a necessary decision, it could still create frustration and confusion for parents. Key Takeaways The FDA is delaying its meeting to review the safety and effectiveness of the Pfizer COVID-19 vaccine for kids under 5....

Key TakeawaysA new draft guidance from the FDA indicates that the agency may gather more safetyinformation on dietary supplements.Manufacturers would be required to submit late notifications if their products contain new dietary ingredients.This guidance is still far from an extensive reform of dietary supplement regulations. Key Takeaways A new draft guidance from the FDA indicates that the agency may gather more safetyinformation on dietary supplements.Manufacturers would be required to submit late notifications if their products contain new dietary ingredients....

Key TakeawaysFDA granted its full approval of the Pfizer COVID-19 vaccine.Pfizer’s vaccine will be marketed under the brand name Cormirnaty.Officials hope the FDA approval will persuade vaccine-hesitant people to get vaccinated. Key Takeaways FDA granted its full approval of the Pfizer COVID-19 vaccine.Pfizer’s vaccine will be marketed under the brand name Cormirnaty.Officials hope the FDA approval will persuade vaccine-hesitant people to get vaccinated. The Food and Drug Administration (FDA) on Mondaygranted full approvalto Pfizer’s COVID-19 vaccine....

Key Takeaways The Food and Drug Administration (FDA) approved Pfizer’s vaccine againstrespiratory syncytial virus, or RSV, for adults 60 and older earlier this week.This marks the second available RSV vaccine in the United States after a version from pharmaceutical company GSK earned approval last month. A New Vaccine Could Save the Lives of Over 6,000 Older Adults Each Year Record-high RSV cases collided with influenza and COVID-19 to cause what somepublic health expertscalled a “tripledemic” of respiratory illness last winter....

Key TakeawaysThe FDA has authorized use of the Moderna, Pfizer, and Johnson & Johnson COVID-19 booster dose.The FDA says adults (18+) do not have to get a booster dose of the same brand of vaccine they originally received. Key Takeaways The FDA has authorized use of the Moderna, Pfizer, and Johnson & Johnson COVID-19 booster dose.The FDA says adults (18+) do not have to get a booster dose of the same brand of vaccine they originally received....

Key TakeawaysA panel of independent advisors to the FDA met last week to discuss the agency’s proposal to simplify the COVID-19 vaccine program.The group voted unanimously to recommend giving the same vaccine formula for the primary series and booster shots.Panelists proposed a June meeting to discuss which variants to target so that updated vaccines will be ready to administer in the fall. Key Takeaways A panel of independent advisors to the FDA met last week to discuss the agency’s proposal to simplify the COVID-19 vaccine program....

Key Takeaways “This emergency authorization allows us to make a COVID-19 treatment available for recently diagnosed, high-risk patients – adding a valuable tool for doctors fighting the now-increasing burden of this global pandemic,” Dave Ricks, Eli Lilly’s chairman and CEO, said in a news release. The possibility of viable treatment comes at a time when COVID-19 is infecting more than 140,000 people per day. The treatment, called bamlanivimab (LY-CoV555), has been authorized for the treatment of mild to moderate COVID-19 in adults and children 12 years and older with a positive COVID-19 test, and who are at high risk for progressing to severe COVID-19 and/or hospitalization, according to the company’s statement....

Key Takeaways Teenagers and adults who are hooked on Juul’s compact e-cigarettes might have to search for alternatives. The Food and Drug Administration (FDA) on ThursdayorderedJuul to remove all of its e-cigarette products from the U.S. market. It was one of the most sweeping actions the FDA has taken against vaping products in recent years. In its announcement, the agency said that Juul provided “insufficient and conflicting data” on potentially harmful chemicals leaching from the refill pods....

UPDATEOn October 20, theFDA authorizeda single booster of the Johnson & Johnson COVID-19 vaccine at least 2 months after initial vaccination in adults 18 and up. The FDA also said COVID booster shots do not have to match a recipient’s initial vaccine series. In other words, vaccines can be “mixed and matched.” UPDATE On October 20, theFDA authorizeda single booster of the Johnson & Johnson COVID-19 vaccine at least 2 months after initial vaccination in adults 18 and up....

UPDATEOn October 20, theFDA authorizeda single booster of the Moderna COVID-19 vaccine at least 6 months after initial vaccination series. This authorization is for adults 65 and up, as well as adults 18 and up who are at risk for serious illness or COVID exposure at work. The FDA also said COVID booster shots do not have to match a recipient’s initial vaccine series. In other words, vaccines can be “mixed and matched....