With updated Phase I/Ib data in hand, Arcus will launch a Phase III trial as it aims to compete with Merck, whose drug ...

Following Merus’ splash last month with a “best-in-disease profile” for its head and neck cancer bispecific, Bicara touted ...

Jefferies analysts said the approval was largely expected and an “incremental positive” for Moderna amid questions about the ...

The overturning of the FDA’s lab-developed tests rule is just the tip of the iceberg. With the loss of Chevron deference, ...

In 2018, the FDA began an investigation into nitrosamine impurities in drugs that led to high-profile recalls for heartburn ...

Arguably the most notable of the FDA’s upcoming decisions is that regarding Gilead’s twice-yearly HIV prophylaxis lenacapavir ...