The FDA clearance aids AstraZeneca and Daiichi Sankyo’s plan to position ADCs like Enhertu ahead of chemotherapy in a variety of tumors.

Enhertu first secured approval in 2019 for patients with high levels of HER2, a protein that promotes cancer cell growth. In 2022, the drug became the first therapy approved for H

A Food and Drug Administration project to promote diversity in clinical studies of cancer treatments was removed from the agency's website, as the Trump administration halts DEI initiatives.

In a bombshell announcement made last week, the Food and Drug Administration (FDA) said it will ban the use of FD&C Red No. 3, a synthetic food dye, from the nation’s food supply. The latest initiative comes more than three decades after the colorant was barred from cosmetics and non-oral medications due to potentially causing cancer.

The FDA expanded the approval of trastuzumab deruxtecan for treatment of breast cancer.The new indication applies to use of the agent by patients with HER2-low or HER2-utralow metastatic breast cancer whose disease progressed after at least one endocrine therapy.

The antibody drug conjugate was approved for patients with unresectable or metastatic HER2-low or -ultralow breast cancer with disease progression after endocrine therapy.

A Belgian court dismissed a lawsuit against EU chief Ursula von der Leyen centered on text messages she exchanged with Pfizer's CEO during negotiations for Covid shots.

AstraZeneca AZN and partner Daiichi Sankyo announced that the FDA has approved the supplemental biologics license application (sBLA) seeking approval for expanded use of Enhertu (trastuzumab deruxtecan) for HER2-low metastatic breast cancer in the United States.

Northwell Health partnered with Stacker to explore how a new Pap smear alternative may help prevent deaths from cervical cancer.

The FDA approved trastuzumab deruxtecan for adult patients with unresectable or metastatic HER2-low or HER2-ultralow breast cancer, based on phase 3 DESTINY-Breast06 trial results.

The FDA has banned red dye No. 3 in food and ingested drugs, the agency announced. But what exactly is red dye No. 3, and why is it being banned? Here's what you need to know.

The approval is based on findings from a phase 3 study which demonstrated the drug’s superiority over chemotherapy.