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

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 ...

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

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

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

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

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

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 ...

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

As the prospect of sector-specific tariffs under the second Trump administration continues to rattle drugmakers, a more fundamental threat to the U.S. | Staff cuts at the FDA have reached key ...

After a batch of much-anticipated reciprocal tariffs spared pharmaceuticals in early April, drugmakers, medtech companie | ...