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.
By Pierre Bertrand Roche said that the U.S. Food and Drug Administration has designated its Inavolisib breast cancer treatment as a breakthrough therapy.
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.
Swiss drug major Roche Holding AG (RHHBY) and its U.S. Unit Genentech announced Tuesday that the U.S. Food and Drug Administration ...
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 designation ...
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Sarclisa accepted for FDA priority review for the treatment of transplant-ineligible newly diagnosed multiple myeloma FDA Priority Review granted based on positive results from ...