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 ...

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

The FDA will allow a new dosing schedule for Eli Lilly’s Alzheimer’s drug Kisunla that could lessen a known side effect of ...

Actithera’s radiopharma assets irreversibly bind to their targets, allowing for longer retention of the drug inside tumors.

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

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

After issues with a batch of Jasper Therapeutics' investigational antibody led to "lower" therapeutic effects in several ...

A readout from the company’s SUMMIT trial put its small molecule bezuclastinib on a collision course with rival Blueprint’s ...

Despite rehiring hundreds of FDA, CDC and NIH employees, the Department of Health and Human Services is still a skeleton of ...

After a season of regulatory upheaval, obesity and rare genetic diseases will likely remain major themes for biopharma in ...

Ekterly’s road to approval was not a smooth one. Last month, the FDA informed KalVista it would not meet its PDUFA date due ...