Aug. 31, 2022 – The FDA on Wednesday granted emergency use authorization to Omicron-specific COVID-19 vaccines made by Pfizer/BioNTech and Moderna. The agency cited data to support the safety and efficacy of this next generation of mRNA vaccines targeted toward variants of concern. If you’ve been waiting to get a variant-specific booster shot, you may … Read more
Editor’s note: This story was updated at 4:28 p.m. March 29, 2022 — The FDA said Tuesday that it approved fourth doses of COVID-19 vaccines for many Americans to protect the most vulnerable people against severe COVID-19 illness, hospitalization, and death. According to an FDA news release, anyone over 50, and people over 18 who … Read more
By Robert Preidt and Robin FosterHealthDay Reporter FRIDAY, March 25, 2022 (HealthDay News) — The U.S. Food and Drug Administration authorized several tobacco-flavored vaping products made by the company Logic on Thursday, and added that it would soon announce whether other big-name brands can continue to sell their products in this country. The agency said … Read more
Dec. 22, 2021 – The FDA on Wednesday granted emergency use authorization of a new antiviral pills to treat people with symptomatic COVID-19. Pfizer’s ritonavir, name brand Paxlovid, can now be taken by patients age 12 and up who weigh at least 88 pounds. The antiviral is only for people who test positive for coronavirus, … Read more
Dec. 9, 2021 — The FDA has authorized booster doses of Pfizer’s COVID-19 vaccine, clearing the way for millions of teenagers to get a third dose of vaccine starting 6 months after their second dose. The FDA said it was basing its emergency authorization of boosters for 16 and 17 year olds on data from … Read more
Oct. 29, 2021 — The FDA has authorized Pfizer’s COVID-19 vaccine for children ages 5 to 11, which means vaccines could be available to school-aged children starting next week. The move brings families with young children a step closer to resuming their normal activities, and it should help further slow transmission of the coronavirus in the U.S. … Read more
By Robert Preidt and Robin FosterHealthDay Reporter WEDNESDAY, Oct. 13, 2021 (HealthDay News) — The U.S. Food and Drug Administration on Tuesday announced its first authorization of an electronic cigarette. The permission to sell was granted to R.J. Reynolds for three of its Vuse tobacco-flavored vaping products. “Today’s authorizations are an important step toward ensuring … Read more
May 10, 2021 — The FDA on Monday granted emergency use authorization for the Pfizer coronavirus vaccine to be given to children 12-to-15 years old. The much-expected decision increases the likelihood that schools in the United States will fully reopen in the fall — a goal of both the Biden and Trump administrations. … Read more
Dec. 18, 2020 — As expected, the FDA granted Moderna an emergency use authorization for its COVID-19 vaccine, doubling the number of vaccine doses expected to be available in the coming days for distribution nationwide. There is one final step — the CDC’s Advisory Committee on Immunization Practices will need to recommend its use, … Read more
Nov. 19, 2020 — The FDA on Thursday granted emergency use authorization for the arthritis drug baricitinib to be used in combination with remdesivir to treat hospitalized adults and children with suspected or confirmed COVID-19. The combination is meant for patients who need supplemental oxygen or mechanical ventilation. Baricitinib plus remdesivir was shown … Read more