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 ...

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.

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 ...

The U.S. Food and Drug Administration on Thursday publicly shared over 200 archived so-called complete response letters ...

The FDA granted accelerated approval to sunvozertinib for adult patients with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations. This approval specifically targets ...