Marty Makary says the FDA will plow ahead with big plans on ultra processed foods, dietary guidelines, and expedited drug and ...

The FDA recently unveiled a new national priority voucher program that would seek to trade faster drug approvals for lower ...

The appointment of a seasoned pharmaceutical executive, George Tidmarsh, to run the FDA’s drug center underscores the ...

In recent years, Artificial Intelligence (AI) has made significant strides across various sectors, providing innovative solutions and enhancing efficiency. However, ...

On average, it costs $880 million to get a completely new medication through the FDA approval process. That number can easily surpass $1 billion if there are any issues with trials or data.

The US FDA has published more than 200 complete response letters sent as replies to drug and biological product applications.

The mention of risks related to the FDA approval process for etripamil raises concerns about the drug's market potential and the company's future revenue streams.

Moderna reports that it has received full approval from the U.S. Food and Drug Administration for its COVID-19 vaccine, Spikevax.

The company announced the FDA’s full approval in a statement July 10, noting its COVID-19 vaccine, mRNA-1273, was previously available for pediatric populations under emergency use authorization. The ...