Two months after Roche unveiled clinical trial data that could help bring its breast cancer drug Kadcyla to early-stage patients, the company has won a speedy FDA review. And if Roche succeeds ...

Roche Holding AG said an experimental breast-cancer treatment will get an expedited review from US regulators ... is based on research showing the medicine, called inavolisib, could offer a ...

Roche's Itovebi was the first PI3K inhibitor to get approved ... has an FDA green light as part of a combination regimen for patients with advanced HR-positive, HER2-negative breast cancer with ...

Basel, 29 May 2024 - Roche (SIX ... or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment. The Priority Review is based on the ...

Roche said the U.S. Food and Drug Administration (FDA) gave priority review to Tecentriq mixed with the chemotherapy Abraxane for initial treatment of people with metastatic triple-negative breast ...

FDA pertuzumab U.S. approval decision due by June 8 Drug is used with Herceptin in HER2-positive patients Roche shares up 1.9 percent Feb 7 (Reuters) - U.S. health regulators granted a priority ...

A second Phase III INAVO122 study (NCT05894239) is evaluating Itovebi in combination with Roche’s other FDA-approved breast cancer therapy Phesgo (pertuzumab, trastuzumab, and rHuPH20 ...

The FDA has approved Swiss pharmaceutical company Roche’s first companion diagnostic for identifying those patients with HER2 low-metastatic breast cancer who are eligible for ENHERTU.