Roche Holding AG said an experimental breast-cancer treatment will get an expedited review from US regulators after showing ...
The US Food and Drug Administration (FDA) has granted Roche a breakthrough therapy designation for its breast cancer therapy ...
By Pierre Bertrand Roche said that the U.S. Food and Drug Administration has designated its Inavolisib breast cancer treatment as a breakthrough therapy.
(RTTNews) - Swiss drug major Roche Holding AG (RHHBY) and its U.S. Unit Genentech announced Tuesday that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation for ...
NEW YORK – The US Food and Drug Administration has accepted and granted priority review to Genentech's new drug application (NDA) seeking approval for its PI3Kα inhibitor inavolisib as a treatment in ...
Priority Review ... breast cancers that harbour PIK3CA mutations,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We welcome the FDA ...
AstraZeneca and Daiichi Sankyo will discuss with regulators the latest DESTINY-Breast06 data presented at ASCO in the hopes ...