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At the San Antonio Breast Cancer Symposium in December, Roche presented the data from its phase 3 Katherine trial, a head-to-head test of Kadcyla versus Herceptin in 1,500 patients.
Roche Holding AG said an experimental breast-cancer treatment will get an expedited review from US regulators after showing it helped patients live longer without the disease progressing.
Roche said the new Kadcyla nod adds an important postsurgery treatment for early breast cancer patients—and the approval came hard on the heels of new data, thanks to a new and faster FDA review ...
U.S. health regulators granted a priority review for an experimental Roche breast cancer drug that in clinical trials added six months to the time before the disease worsened.
Swiss drugmaker Roche said on Tuesday its Tecentriq medicine will get a speedy review by U.S. regulators in a tough-to-treat form of breast cancer, as it seeks to be the first company to have its ...
Roche's Itovebi was the first PI3K inhibitor to get approved as a first-line treatment for breast cancer last year – and new survival data to be presented at the upcoming ASCO congress looks set ...
FDA grants Priority Review to Roche’s inavolisib for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation F. Hoffmann-La Roche Ltd Wed, May 29, 2024, 1:00 AM 11 ...
The Food and Drug Administration has issued a positive review of a breast cancer drug from Roche that could soon become the first pharmaceutical option approved for treating early-stage disease ...
Pharmaceutical company Roche has submitted an application to the U.S. FDA for its antibody-drug trastuzumab-DM1, which could replace its Herceptin remedy for women with advanced breast cancer.
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