Oncology (Cancer)/Hematologic Malignancies Approval …
Dec 4, 2024 · FDA grants accelerated approval to pembrolizumab for HER2-positive gastric cancer: Food and Drug Administration granted accelerated approval to pembrolizumab (Keytruda, Merck & Co.) in...
Lifileucel First Cellular Therapy Approved for Cancer
Mar 5, 2024 · In an event more than three decades in the making, the Food and Drug Administration (FDA) has approved lifileucel (Amtagvi), the first treatment for cancer that uses immune cells called tumor-infiltrating lymphocytes, or TILs.
Oncology Center of Excellence | FDA - U.S. Food and Drug Administration
Dec 5, 2024 · Pediatric Oncology Drug Approvals; Rare Cancers Program – Promoting the development of safe and effective new drugs and biologics to treat patients with rare cancers.
FDA approves first cancer treatment for any solid tumor with a …
The U.S. Food and Drug Administration today granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker).
Darzalex Faspro, Sarclisa Approvals for Multiple Myeloma
Jan 7, 2025 · Two recent approvals by the Food and Drug Administration (FDA) broaden the initial treatment options for people who have a new diagnosis of multiple myeloma. ... The current standard treatment is for patients to stay on maintenance therapy until their cancer starts to progress again—which means continually having to deal with side effects ...
Overall survival benefits of cancer drugs initially approved by the …
May 13, 2024 · New cancer drugs can be approved by the US Food and Drug Administration (FDA) on the basis of surrogate endpoints while data on overall survival are still incomplete or immature, with too few deaths for meaningful analysis.
US Food and Drug Administration Approval Summary: Fam …
In December of 2019, the US Food and Drug Administration (FDA) granted T-DXd accelerated approval for treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who had received two or more prior anti-HER2–based regimens in the metastatic setting on the basis of results of a single-arm study DESTINY-Breast01 ...
Trends in the approval of cancer therapies by the FDA in the …
Jun 21, 2023 · This Review summarizes trends in the approval of oncology therapeutic products by the United States Food and Drug Administration (FDA) from January 2000 to October 2022, based on a...
Opdualag Approved to Treat Advanced Melanoma - NCI
Apr 6, 2022 · The Food and Drug Administration (FDA) has approved a combination of two immunotherapy drugs for the treatment of some people with advanced melanoma. The combination consists of relatlimab and nivolumab (Opdivo) and will be …
US bans red dye No. 3 from food, candy and medicine - BBC
5 days ago · Manufacturers will no longer be allowed to use the dye, called red No 3 or red dye 3, after studies linked it to cancer in male laboratory rats, the US Food and Drug Administration (FDA) announced ...