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 ...

President Donald Trump’s One Big Beautiful Bill, signed into law last week, reintroduces broader exemptions for orphan drugs ...

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

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

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

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

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