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Roche Breast Cancer Medicine to Get Expedited FDA Review(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 ...
One possible explanation for the gap is the availability of highly efficacious CAR-T therapies in the U.S. and Europe serving as later-line therapies to improve survival outcomes. The FDA has also ...
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.
Roche’s Herceptin and Perjeta duo is already part of a well-established standard of care in early-stage HER2-positive breast ...
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 ...
The FDA has granted fast-track approval to the drug telisotuzumab vedotin (sold as Emrelis) as a first-of-its-kind treatment for certain people who have non-squamous non-small-cell lung cancer.
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 ...
Roche has claimed a breakthrough designation from the FDA for a cancer test that combines an antibody assay with artificial-intelligence-powered analysis to provide what the company says could ...
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 ...
The test detects the MET protein that is over-expressed in some patients with non-squamous non-small cell lung cancer.
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