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 ...

The medium-sized biopharma is showing off new results from dordaviprone and Zepzelca, both of which were acquired through ...

Despite mixed results, analysts maintained faith in ivonescimab’s ability to cross over between Eastern and Western patient ...

Although the FDA has rejected Stealth’s new drug application for Barth syndrome candidate elamipretide, the agency identified ...

Analysts at Truist Securities admitted that the result for itepekimab, which the companies were hoping to follow their ...

Patritumab deruxtecan was unable to significantly improve overall survival in patients with locally advanced or metastatic ...

According to President Trump, CMS Administrator Mehmet Oz is a “tough hombre” who can bring down drug costs “like a rock.” ...