FDA Approves Inavolisib with Palbociclib and Fulvestrant for Advanced Breast Cancer

On October 10, 2024, the FDA approved Inavolisib in combination with Palbociclib and Fulvestrant for adults with advanced, endocrine-resistant, HR-positive, HER2-negative breast cancer with PIK3CA mutations.

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FDA approval means that a drug or medical treatment has been carefully tested and proven to be safe and effective for people to use. The U.S. Food and Drug Administration (FDA) gives this approval after looking at data from clinical trials. These trials are research studies with human participants that test how well a new treatment works and what side effects it may have. Clinical trials happen in different stages and provide the important information the FDA needs to make sure a product is safe and meets quality standards before it can be sold to the public.