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(Bloomberg) -- 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 ...
Roche RHHBY obtained a Breakthrough Therapy Designation for its investigational oral therapy inavolisib for treating adult breast cancer patients in the United States. The FDA granted this ...
The green light comes after a six-month priority review by the FDSA and is a big step up for Roche’s drug, which has the opportunity to build a presence in breast cancer ahead of earlier-to ...
Roche, hoping to carve out a standard-of-care spot for its PI3K inhibitor Itovebi, now has another leg to stand on with new ...
Swiss pharma company Roche ... FDA Priority Review status for a Perjeta (pertuzumab) regimen to be used before surgery (neoadjuvant treatment) in people with HER2-positive early stage breast cancer.
A group of advisers to the Food and Drug Administration said Roche Holding AG needs to study its blood cancer treatment in ...
A study involving an experimental cancer drug being developed by Roche Holding (RHHBY, ROG.VX) showed it delayed disease progression in women with a specific type of breast cancer compared to ...
ZURICH -- Roche Holding AG (ROG.VX ... closer to the approval of a new personalised medicine for people with this aggressive form of breast cancer," said Hal Barron, Roche's Chief Medical Officer ...
The Itovebi, Ibrance, and fulvestrant combination demonstrated improved survival outcomes versus placebo in a Phase III trial.