The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to brelovitug (BJT-778) for the treatment of chronic hepatitis delta (CHD).

The U.S. Food and Drug Administration has approved Enhertu (trastuzumab deruxtecan) for the treatment of adult pat ...

In this video, Xiuning Le, MD, PhD, discusses how the definition of EGFR-mutated lung cancer has expanded in recent years.

The FDA's new Breakthrough Therapy designation may offer oncology brands a powerful way forward – and some challenges for market research. Phase III in oncology – between a rock and a hard ...

AstraZeneca (AZN) and Daiichi Sankyo’s ENHERTU has been approved in the US for the treatment of adult patients with unresectable or metastatic ...

Aspirin reduced recurrence by 50% in PIK3CA-mutated colorectal cancer, the DCISionRT test earned FDA breakthrough status for predicting radiotherapy benefit in DCIS, and nivolumab plus chemotherapy ...

An innovative treatment for debilitating and often deadly cases of recurrent C diff infection has been given a Breakthrough Therapy Designation by the FDA. Developed by US biotech firm Rebiotix ...

FDA approves Enhertu for metastatic breast cancer with HER2-low or HER2-ultralow expression after showing significant ...

The FDA approves AstraZeneca's sBLA for Enhertu to treat HER2-low or HER2-ultralow metastatic breast cancer in the United ...

AstraZeneca (AZN) and Daiichi Sankyo's (DSKYF) drug Enhertu has been approved by the FDA for the treatment of certain breast cancer patients. Read more here.

Approval of Enhertu marks the first HER2-directed therapy indicated for adults with unresectable or metastatic HR-positive, ...