In its complete response letter, the FDA cited insufficient evidence establish deramiocel's effectiveness for cardiomyopathy ...

The trove of more than 200 letters is part of a pledge of transparency from the agency, with the intention to increase public ...

The approval of Moderna's Spikevax for kids at higher risk of contracting the disease continues the company's regulatory ...

A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...