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 progressing.

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 ...

Roche RHHBY announced that the FDA has approved pipeline candidate, inavolisib, for the treatment of breast cancer, under the brand name Itovebi. The drug is approved in combination with Pfizer ...

FDA grants Priority Review to Roche’s inavolisib for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation F. Hoffmann-La Roche Ltd Wed, May 29, 2024, 1:00 AM 11 ...

Genentech, part of the Roche Group ( OTCQX:RHHBY) ( OTCQX:RHHBF) ( OTCPK:RHHVF ), announced that the U.S. FDA has rejected ...

Roche Holding said the U.S. Food and Drug Administration granted priority review to the company's new drug application for inavolisib as a treatment for a type of advanced breast cancer.

The Food and Drug Administration (FDA) granted a breakthrough therapy designation to the novel drug inavolisib to be used in combination with Ibrance (palbociclib) and fulvestrant to treat patients ...

The FDA has given Roche its first regulatory approval for PI3K inhibitor Itovebi, clearing the drug as part of a triple therapy for certain types of locally advanced or metastatic breast cancer.

Roche RHHBY announced that the FDA has approved pipeline candidate, inavolisib, for the treatment of breast cancer, under the brand name Itovebi.. The drug is approved in combination with Pfizer ...