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 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 ...

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

Slashing adverse drug reactions through pharmacogenetics and advanced AI could help rehabilitate the pharmaceutical ...

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

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

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

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