FDA, Covid-19
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Federal health officials will no longer routinely approve annual COVID-19 shots for younger adults and children who are healthy
The FDA also gave full approval to the Novavax COVID vaccine (Nuvaxovid) using this approach, approving it for those ages 65 and up, along with people ages 12 and up who have at least one underlying condition that puts them at risk of severe disease.
FDA FLAGS SEVERE ITCH — Patients who stop using the oral allergy medicines cetirizine (Zyrtec) or levocetirizine (Xyzal) may experience rare but severe itching after longtime use, the FDA has cautioned.
The rollout of updated Covid vaccines for healthy children and adults this fall is likely to be delayed after the FDA said it will require another clinical trial.
Agency will ask drugmakers for large trials for new versions of vaccines meant for healthy adults and children.
President Donald Trump’s administration is slated to lay out its approach to Covid vaccination at an event Tuesday that could spell major changes in what is required to get regulatory approval for immunizations.
Mexico halts Brazilian poultry imports after a bird flu outbreak, the U.S. FDA conditionally approves Novavax's COVID vaccine, and allows the first Alzheimer's blood test. Meanwhile, Assura is outbid by PHP in a takeover,
The head of the Food and Drug Administration said the agency will soon unveil a new framework detailing what companies must do to seek approval of vaccines, a move that comes as the Trump administration has introduced uncertainty into the annual process for green-lighting updated coronavirus shots traditionally offered in the fall.