The test results do not rule out co-infection with other viruses or bacteria, the FDA said. Read More

The EUA decision was based on positive results from two studies. Read More

The trial aimed to include 316 participants with early-onset COVID-19 but was halted in March with just 84 patients enrolled. Read More

The company plans European distribution of the new rapid tests within weeks. Read More

No complaints or reports of injuries or deaths have been associated with the recalled tests, the agency said. Read More

COVID-19 exposed supply chain problems that should have pharmaceutical manufacturers rethinking their standard procedures — from sourcing manufacturing materials to getting completed product safely into customer hands, — says one regulatory compliance expert. Read More

The financial terms of the deal were not disclosed. Read More

Moderna also plans to file an emergency use application for children aged six months to under six years. Read More

The company plans to expand the use of the home collection kit through partnerships with other authorized laboratories. Read More

Paxlovid is currently FDA-authorized for treatment of mild-to-moderate COVID-19 in adults and pediatric patients 12 years of age and older weighing at least 40 kg. Read More

The EMA said it will continue to assess any new data on the two vaccines and will take action to protect patients if needed. Read More

The panel concluded that the absence of in vitro neutralization activity strongly suggests absence of clinical effectiveness of these monoclonal antibodies. Read More