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

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

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

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

Partners Ultragenyx and Mereo BioPharma saw their stocks drop by 21% and 30%, respectively, after announcing that the Phase ...

The move has sparked concern that the U.S. Preventive Services Task Force could soon be dismissed after a decision by the ...

In this episode presented by Eclipsebio, BioSpace's head of insights Lori Ellis discusses mRNA and srRNA with Andy Geall of ...

The deal gives AstraZeneca’s rare disease unit Alexion access to specialized capsids developed by the Japanese biotech JCR ...

Leerink Partners called the announcement a ‘positive’ given the delayed timeframe and the uncertainty that the administration ...

TIGIT-targeting therapies have largely disappointed in recent months, with failed studies, terminated partnerships and ...

The high court's order blocks a May decision by a California court that temporarily blocked the efforts of Health Secretary ...

The deal marks an end for CAR T company Cargo Therapeutics, which has been slashing its workforce and cutting programs since ...