BREAKING NEWS: FDA seeks probe into communications between its staff and Biogen after controversial approval of Alzheimer’s drug FDA commissioner Janet Woodcock has asked for a probe into her staff’s communications with Biogen Biogen’s Aduhelm received FDA approval for Alzhiemer’s disease in early June despite limited data that it worked in clinical trials By Mansur Shaheen … Read more
BREAKING NEWS: Pfizer asks FDA to expand emergency use of its COVID-19 vaccine to include kids ages 12 to 15 Pfizer Inc has asked the FDA to expand emergency use of its COVID-19 vaccine to Americans between ages 12 and 15 years old Recent clinical trial data found that the vaccine was 100 percent safe … Read more
The U.S. Food and Drug Administration (FDA) has authorized another at-home coronavirus test for emergency use authorization. The test, made by Quidel Corp, can only be gotten with a prescription but does require users to send a sample to a laboratory for analysis. What’s more, it can provide results within 10 minutes, which makes it … Read more
Johnson & Johnson’s one-dose COVID-19 vaccine SHOULD get FDA authorization, expert panel votes: Advisors give unanimous ‘yes’ for America’s third coronavirus shot FDA’s advisory committee recommended that the FDA give emergency approval for J&J’s shot on Friday The shot was 66% effective at preventing mild to moderate infection in trials globally, and 72% effective in … Read more
BREAKING NEWS: FDA analysis finds Johnson & Johnson’s single-dose vaccine does protect against COVID-19 and could be approved as soon as FRIDAY An FDA analysis found Johnson & Johnson’s single-dose vaccine is safe to use and does protect against COVID-19 Officials found the vaccine was 68% effective against the variant in Brazil and 64% effective … Read more
FDA says Moderna can fill its vials with 40% more COVID-19 vaccine to increase the number of doses in each from 10 to 14 and ease production bottlenecks FDA regulators told Moderna it can fill its vials with 40% more vaccine on Friday It comes after Moderna asked regulators to allow more overfill to ease … Read more
The U.S. Food and Drug Administration (FDA) has cleared a new rapid, handheld blood test that could detect whether or not patients have mild concussions. The test, known as iSTAT and manufactured by Abbott Laboratories, looks for specific proteins present in the blood after head trauma. What’s more, results are returned within 15 minutes. Researchers … Read more
FDA head urges states to start giving COVID-19 vaccines to elderly Americans and move on to lower priority groups in a desperate attempt to speed the US rollout’s glacial pace FDA Commissioner Dr Stephen Hahn said it’s ‘reasonable’ to vaccinate lower priority people if states’ doses are going unused The US has only vaccinated 6.25 … Read more
Quickly turning around results of the process to detect the new ‘super-covid’ variant ‘isn’t an urgent need,’ because the findings won’t change how the US handles the pandemic, a CDC official told DailyMail.com. ‘For less urgent sequencing, when there isn’t an urgent need to get the data turned around quickly, it’s much more efficient to … Read more
A former FDA head is urging the US to start vaccinating more groups of Americans against COVID-19 immediately and stop holding back millions of doses to give as booster shots for those who have had the first jab. ‘Right now, every shot in an arm is a win,’ former Food and Drug Administration (FDA) commissioner … Read more