Emergency use of the test is limited to laboratories that meet requirements to perform high complexity tests. Read More

Under the EUA, the agency limits analysis of the test samples to Helix Diagnostics’ laboratory in Waterford, Mich. Read More

The commission is expected to grant the vaccine a conditional authorization sometime this year. Read More

People who took AXA1125 had statistically significant improvements in their level of mental and physical fatigue. Read More

So far, no complaints or reports of injuries or deaths have been linked to the test kits, the FDA said. Read More

Moderna’s bivalent booster has yet to be authorized by the FDA for emergency use. Read More

The test can deliver results on up to 16 samples in less than an hour, the company said. Read More

Analysis of the samples is limited to Predicine’s Hayward, Calif. laboratory. Read More

The company plans on submitting the test to the FDA for Emergency Use Authorization and 510(k) clearance. Read More

If approved, Xocova would be the third COVID-19 oral treatment approved in Japan. Read More

“If you have been waiting for a COVID-19 vaccine built on a different technology than those previously available, now is the time to join the millions of Americans who have been vaccinated,” said CDC Director Rochelle Walensky. Read More

The test must be administered twice, with 24-48 hours between each test. Read More