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 ...

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

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 ...

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

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

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

Nuclidium’s radiopharmaceutical platform is unique in its use of copper-based payloads, which the biotech claims can deliver higher doses while also being safer.

BrainStorm Cell Therapeutics issued a statement Tuesday supporting a Citizens’ Petition submitted to the FDA requesting the ...