In the first phase 3 trial to show the superiority of a TROP2-targeted antibody-drug conjugate and an immunotherapy agent in ...

The two highest-ranking leaders within the FDA’s Office of Prescription Drug Promotion (OPDP) have stepped down, according to ...

AstraZeneca and Daiichi Sankyo are aiming to establish their star antibody-drug conjugate (ADC) Enhertu as a first-line ...

For a second time in less than a month, a new CDMO has uncloaked.  | For a second time in less than a month, a new CDMO has ...

Particulate contamination has sparked the recalls of numerous injectable drugs over the years, with Amneal’s hospital med ...

The FDA has sent Regeneron a complete response letter, rejecting its bid to stretch the administration of high-dose Eylea ...

When Phathom Pharmaceuticals launched its first direct-to-consumer ads for Voquezn | In a commercial debuting Monday, Kenan ...

Pharma brands spend billions annually trying to engage healthcare providers (HCPs), yet much of this outreach has a limited ...

On its way to generating sales of $14 billion in just its seventh full year on the market, Sanofi and Regeneron’s Dupixent ...

An investigation into the national security implications of pharma imports has been underway for two weeks, the Trump ...

As tariff threats and FDA staff cuts thrust the biopharma world into uncharted waters, President Donald Trump is offering the ...

Employees of companies regulated by the FDA—such as pharmas or biotechs—are no longer allowed to serve as members of FDA ...