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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 ...
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.
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 has claimed a breakthrough designation from the FDA for a cancer test that combines an antibody assay with ...
The FDA’s Oncologic Drugs Advisory Committee (ODAC) is planning to host its first meeting under new agency commissioner Marty ...
The FDA has cleared Delcath Systems to start a phase 2 trial for Hepzato in liver-dominant metastatic breast cancer. The trial will compare Hepzato plus standard care against standard care alone 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 ...