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
The antibody drug conjugate was approved for patients with unresectable or metastatic HER2-low or -ultralow breast cancer with disease progression after endocrine therapy.
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.
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.
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.
Northwell Health partnered with Stacker to explore how a new Pap smear alternative may help prevent deaths from cervical cancer.
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.
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 FDA issued a ban on the use of red dye No. 3 in food and beverage products and ingested drugs. The synthetic dye has been linked to cancer in animal studies and was banned more than 30 years ago in cosmetics and topical drugs.
The approval is based on findings from a phase 3 study which demonstrated the drug’s superiority over chemotherapy.
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 clearance is a step forward in AstraZeneca and Daiichi Sankyo’s plan to position antibody-drug conjugates like Enhertu ahead of chemotherapy in a variety of tumors.