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.

Two months after Roche unveiled clinical trial data that could help bring its breast cancer drug Kadcyla to early-stage patients, the company has won a speedy FDA review.

Priority Review recognises the best-in-class potential of the inavolisib-based regimen for patients in urgent need of new treatment options1,2Additional analyses of INAVO120 will be presented in ...

Itovebi won US Food and Drug Administration (FDA) approval in this breast cancer indication based on INAVO120’s data late last year, although full analysis of the OS has only been completed by ...

Roche (OTCQX:RHHBY) has received FDA approval for its drug Itovebi in combination with two other drugs for the treatment of a certain type of breast cancer with a PIK3CA mutation.

Roche and Lilly said they believe the test could play an important role in improving access to early and accurate Alzheimer's diagnosis.

Roche's Itovebi was the first PI3K inhibitor to get approved as a first-line treatment for breast cancer last year – and new survival data to be presented at the upcoming ASCO congress looks set ...

AbbVie and Genmab have glided into Roche’s slipstream in the race to bring a CD3xCD20 bispecific to market, securing FDA priority review.

The FDA has completed its 30-day review of an application for Hepzato in combination with standard of care in liver-dominant metastatic breast cancer.

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.