A “heavy workload” and “limited resources” have left the agency unable to meet a June 17 deadline to approve a therapy ...

Novavax, Inc. faces profitability challenges despite a promising tech platform, with uncertain revenue streams. Click for my ...

FDA drug alerts in infectious diseases, including new drug approvals, safety warnings, recalls, and changes in indications.

The FDA has approved Nuvaxovid to prevent COVID-19 in adults 65 years and older and high-risk individuals 12 through 64 years.

Novavax NVAX announced encouraging results from an initial cohort of a late-stage study evaluating its experimental ...

Novavax's combo and standalone flu vaccines showed strong immune responses and good safety in a Phase 3 trial of adults 65 ...

The FDA is adopting a new regulatory framework that will change the criteria for approval of COVID-19 vaccines.

Novavax, Inc. (NVAX) on Wednesday said that its COVID-19-Influenza combination and stand-alone Influenza vaccine candidates ...

The U.S. Food and Drug Administration has approved a new lower-dose vaccine for active immunization against COVID-19 caused ...

Jefferies analysts said the approval was largely expected and an “incremental positive” for Moderna amid questions about the FDA’s attitude toward mRNA and COVID-19 vaccines that have investors ...

Moderna announced this weekend that the Food and Drug Administration approved its lower-dose Covid-19 vaccine for adults 65 and older.

After years of strategic pivots and battling the bureaucracy, Novavax (NASDAQ:NVAX) has finally secured full FDA approval of their COVID-19 vaccine, NUVAXOVID. Not only does the BLA approval ...