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 Recent clinical trial data found that the vaccine was 100 percent safe and … Read more
A ‘tsunami of deaths’ is about to crash over the U.S. in the wake of the COVID-19 pandemic and already-rising rates of chronic disease among Americans, a former Food and Drug Administration (FDA) official is warning. Dr Robert Califf, a former FDA commissioner, predicted that the U.S. will see a surge in chronic illnesses like … Read more
The firm that makes Marlboro cigarettes has boldly asked US health regulators to help it convince Americans that nicotine is not that bad for them – and spend $100 million toward the effort, according to a Bloomberg report. Marlboro’s maker, Altria, wants the Food and Drug Administration (FDA) to back its advertising campaign to inform … 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
America is one step closer to having a one-dose COVID-19 vaccine after an expert panel voted that the Food and Drug Administration (FDA) should authorize the shot on Friday. The panel voted unanimously – 22 to zero – in favor of the vaccine, which was found to be 66 percent effective in trials in the … Read more
No more ultra-cold! FDA says Pfizer’s coronavirus vaccine can be shipped and stored at REGULAR freezer temperatures instead of -76ºF in a move to ease rollout FDA approved PFizer’s request to store its COVID-19 vaccine at -13°F to 5°F for up to two weeks Previously, the shot had to be kept at ultra cold temperatures … Read more
Johnson & Johnson’s single-dose vaccine protects against COVID-19, according to an analysis by the U.S. Food and Drug Administration (FDA) released on Wednesday. The federal agency’s scientists confirmed that, overall ,the vaccine is about 66 percent effective at preventing moderate to severe COVID-19. What’s more, the shot appears to offer more protection against new, variants … Read more
AstraZeneca expects to get US emergency authorization for its COVID-19 vaccine in April, the firm’s president told lawmakers on Tuesday. As soon as it gets the Food and Drug Administration’s (FDA) greenlight, AstraZeneca will have 30 million doses of the 62 percent effective shot ready to ship to the US, said president of the biopharmaceuticals … Read more
Pfizer and partner BioNTech have asked the U.S. health regulator to relax requirements for their COVID-19 vaccine to be stored at ultra-low temperatures, potentially allowing it to be kept in pharmacy freezers, they said on Friday. Approval by the Food and Drug Administration (FDA) could send a strong signal to other regulators around the world … Read more