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

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 ...

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

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 number of employees laid off and companies letting people go increased year over year during the first half of 2025. BioSpace recaps the five largest layoff rounds, including cuts at Bayer, BMS ...

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

Armed with the latest biological knowledge and cutting-edge computational techniques—and, of course, investor dollars—these ...

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 ...