In comments posted in response to the Trump administration’s pharma tariff investigation, companies and industry groups ...

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

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 ...

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 ...

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 ...

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

According to the nonprofit news outlet NOTUS, at least seven studies cited in the Make America Healthy Again report released ...