The country’s regulator on food, drugs and cosmetics is looking to speed up its approval process, targeting to cut by half ...

Confusion over the FDA delay in granting full approval to Novavax’s Covid-19 vaccine deepened over the weekend, with possible ...

Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global ...

Approval Supports Revenue Growth and Margin Expansion Opportunity, and Substantially Increases Peak Production Output ...

Novavax's COVID vaccine was approved under an emergency use authorization in August 2022, and the company has pursued full ...

THE new Food and Drug Administration (FDA) application procedures are expected to reduce the drug permit process by as much ...

“The review continues to go really well.” While there have been reports from other drugmakers about possible interruptions with FDA matters due to staff layoffs and the ouster of top officia ...

The head of the Food and Drug Administration said Tuesday that the agency is now looking at whether it will still approve COVID-19 vaccines for next winter, citing a lack of data on booster shots.

The notion that we can simultaneously demand expedited approvals while gutting the agency is misguided.

ADMA Biologics receives FDA approval for a process enhancing plasma production yields by 20%, boosting growth and capacity for its products. ADMA Biologics, Inc. has announced the U.S. FDA ...

The FDA has approved a monoclonal antibody to treat individuals aged 12 years and older with generalized myasthenia gravis ...

“Under Secretary Kennedy’s leadership, all new vaccines will undergo safety testing in placebo-controlled trials prior to ...