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

The company plans to introduce this system to the German market in the fourth quarter of this year. Read More

The development of the product was funded by HHS’ Administration for Strategic Preparedness and Response as well as the Biomedical Advanced Research and Development Authority. Read More

Clinical studies with Comirnaty Original/Omicron BA.4-5 are ongoing. Read More

Nearly 145 million people worldwide experienced symptoms during that timeframe. Read More

The product is the first guanidine-free molecular transport medium, FDA-cleared device available in the U.S. Read More

With these new EUAs in place, FDA has decided to no longer authorize the monovalent mRNA COVID-19 booster doses. Read More

The blood test showed more than 90 percent accuracy in a validation study. Read More

In the midst of a pandemic, if you wait for all the data to come in, “you’ve missed the boat,” said FDA Commissioner Robert Califf yesterday regarding the agency authorizing both Pfizer/BioNTech’s and Moderna’s bivalent COVID-19 boosters before any clinical trials on them are complete. Read More

The vaccine demonstrated 80 percent efficacy against the Delta variant of the SARS-CoV-2 virus. Read More