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

The U.S. Food and Drug Administration has approved Datroway (datopotamab deruxtecan-dlnk) for adult patients with ...

Here is a select list of cancer therapies approved by the FDA throughout the month of January, featuring patient populations ...

The new drug is meant to treat specific types of advanced breast cancer which are resistant to hormone therapy.

As seen in the DESTINY-Breast06 trial, approximately 20-25 percent of hormone receptor (HR)-positive, HER2-negative breast cancer patients may be considered HER2-ultralow.1 These patients may now be ...

Roche’s PATHWAY HER2 (4B5) test helps identify patients with HER2-ultralow breast cancer, who may be eligible for targeted ...

Less than two months after an accelerated approval from the FDA, a drug combination featuring Pfizer’s Braftovi has turned in ...

The U.S. Food and Drug Administration has approved Supernus Pharmaceuticals' drug-device combination to treat movement-related symptoms of Parkinson's disease, the drugmaker said on Tuesday.

The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval ...

Roche Holding said the U.S. Food and Drug Administration ... growth of cancer cells. The company said the test is the first and only FDA-approved for assessing HER2-low status since 2022.

Now, scientists have found promise in permanently eliminating the virus, thanks to a drug already approved by the FDA to fight cancer. Once a death sentence, human immunodeficiency virus (HIV ...

Moments after Regeneron CEO Len Schleifer scolded analysts for asking too many questions about the disappointing sales of eye ...