New analysis from Jefferies shows that rare disease and cancer drugs granted the status are especially likely to be approved.

Takeda wanted to create something new in the cell therapy world by combining the technology with T cell engagers. A series of ...

The $48 million award, granted through the Advanced Research Projects Agency for Health, will help Kernal take its in vivo ...

The U.S. government remains shut down, with the FDA closed for new drug applications until further notice; cell and gene ...

As the industry loses one of its key female leaders in GSK CEO Emma Walmsley, BioSpace profiles the women leading the ...

Sanofi’s Orano Med-partnered radioligand therapy AlphaMedix achieved all primary efficacy endpoints, which included a measure of overall response rate, in the mid-stage ALPHAMEDIX-02 study.

In the Phase III FIBRONEER-IPF study, Jascayd demonstrated significant lung capacity improvements over placebo.

When a new medicine enters the market, it’s common for the “high” initial list price to make headlines—which can lead to ...

Six months after his controversial departure from the top spot at the FDA’s biologics division, Peter Marks has landed at Eli ...

Skye Bioscience's nimacimab fell short of investor and company expectations, but showed encouraging weight-loss results when ...

Of the three highest bidders, Pfizer’s purchase proposal for Metsera was the lowest, regulatory documents reveal. The New ...

A new survey from CRB showed that most manufacturing initiatives in the U.S. made in response to tariffs are coming from Big ...