Eli Lilly and Incyte were expecting an approval this weekend from the FDA for their blockbuster-in-waiting arthritis candidate baricitinib, but today announced…

A new survey of U.S. scientists, FDA researchers and biomedical clinicians has found that most are concerned over FDA Commissioner nominee Scott Gottlieb’s…

A bill tabled by senior Democrats would set up a $2 billion prize fund that will try to encourage the development of more effective antibiotics for serious…

The Securities and Exchange Commission (SEC) has charged 27 companies and individuals over allegations of fraudulent promotion of stocks, as it says it has…

The FDA has awarded Regeneron breakthrough status for evinacumab, a potentially first-in-class drug designed to help patients who struggle to meet cholesterol…

As it continues its sales push for the controversial Duchenne med Exondys 51 (eteplirsen), Sarepta has taken on a new chief medical officer to help it develop…

Kite Pharma completed an FDA submission for its CAR-T therapy hours before its self-imposed target passed.

Scott Gottlieb's close links to the pharma industry have threatened to undermine his chances of becoming FDA commissioner—but he thinks he has a solution.

Corbus Pharmaceuticals has posted positive top-line data from its midstage trial of Resunab in certain cystic fibrosis (CF) patients as it plots future trials…

Regulatory