Vanda Pharmaceuticals has scored a legal win in its long-running dispute with the FDA surrounding the agency's 2018 rejection of Hetlioz in jet lag disorder. Afte...

A major makeover is underway at a former AbbVie biologics plant in England, which Pharmaron purchased for $119 million in 2021. In January, the Chinese CDMO kicke...

It’s been more than a year since Boehringer Ingelheim and Eli Lilly’s Jardiance became the first drug to score approvals for the two major types of heart failure (HF...

In an effort to bolster drug access in dozens of countries around the globe, three generics makers have obtained sublicenses to make low-cost versions of GSK’s long-...

While forging ahead in this year’s #FierceMadness Drug Ad Tournament, Intra-Cellular Therapies’ Caplyta has ginned up what analysts view as a sweeping trial win in t...

After months of COVID-related delays, the FDA’s reviews of two China-made PD-1 cancer immunotherapies are finally moving forward. The FDA has scheduled a manufact...

Johnson & Johnson will do the two-step all the way to the U.S. Supreme Court. After an unsuccessful bid to get its appeal reheard in the Third Circuit Court o...

GSK has teamed up with Earvin “Magic” Johnson to “Sideline RSV.” Working with the former basketball star and public health advocate, GSK is raising awareness of the ...

Sometimes, the second time is the charm. After a 2021 complete response letter from the FDA for approval in a different indication, the agency has now green-lit Incy...

Nearly three years after dosing the first patient in a phase 3 trial, GSK has now reported positive results from the trial of its much-anticipated combination mening...