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 inavolisib, based on positive results from its recent Phase III trial.
J&J (JNJ) and Merck (MRK) announce the acquisitions of private biotechs. The FDA grants Priority Review tags to Sanofi's (SNY) and Roche's (RHHBY) regulatory applications.
(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 ...
By Pierre Bertrand Roche said that the U.S. Food and Drug Administration has designated its Inavolisib breast cancer treatment as a breakthrough therapy.
Inavolisib is an oral PI3 kinase (PI3K) inhibitor that dysregulates PI3K signalling in the PI3K/Akt/mTOR pathway, which regulates cell growth and survival. Image Credit: Sundry Photography / ...
AstraZeneca and Daiichi Sankyo will discuss with regulators the latest DESTINY-Breast06 data presented at ASCO in the hopes ...