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

Regeneron’s shares have declined nearly 17% following the failure of the company’s Dupixent follow-up itepekimab.

Actym Therapeutics has strengthened its IP portfolio with two newly issued patents covering its novel STACT™ biological ...

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

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

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, ...

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

Keros will be down to 85 full-time employees after the layoffs and expects to generate annualized savings of $17 million.

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

A February executive order on pharmaceutical price transparency does nothing to change the incentives that keep costs opaque.