FDA D.I.S.C.O.: FDA approval of larotrectinib for advanced malignancies with NTRK gene fusion

FDA medical oncologists discuss the Nov. 26, 2018, accelerated approval of larotrectinib for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, that are either metastatic or where surgical resection is likely to result in severe morbidity, and who have no…

FDA Researchers Advance Science for Vaccines to Prevent Mumps and Whooping Cough

Steven A. Rubin, Ph.D., works with a flask of cells inoculated with mumps virus in the FDA’s laboratories in Silver Spring, MD. In a light-filled lab at the U.S. Food and Drug Administration, a collection of small containers are growing the bacteria that cause whooping cough. In a nearby lab, cultures of the mumps virus…

FDA D.I.S.C.O.: First FDA approval of a CAR T-cell immunotherapy

FDA medical oncologists discuss the first approval of a chimeric antigen receptor (CAR) T-cell immunotherapy. Sanjeeve Bala: Welcome back to the DISCO. Today’s Drug Information Soundcast in Clinical Oncology from FDA’s Oncology Center of Excellence discusses the recent approval of tisagenlecleucel, marketed as Kymriah. Abhilasha Nair: Acute lymphoblastic leukemia is the most common type of…

Prostate Cancer: Symptoms, Tests, and Treatment

Risk factors for prostate cancer include family history, age and race; but new approaches to treatment hold promise. Prostate cancer is the most common cancer among men and the second most common cause of cancer-related deaths among American men. African-American men are more likely to get prostate cancer and twice as likely to die from…

FDA D.I.S.C.O.: FDA approval of cabozantinib for hepatocellular carcinoma

FDA medical oncologists discuss the January 14, 2019, approval of cabozantinib for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. Dr. Sanjeeve Bala: Welcome back to the DISCO, the FDA’s Drug Information Soundcast in Clinical Oncology from the Oncology Center of Excellence. During our soundcasts, we discuss recent FDA approvals of…

How to Safely Use Glucose Meters and Test Strips for Diabetes

When it comes to buying test strips—including glucose test strips designed for your meter—the FDA recommends that you buy new, unopened vials. The FDA recommends that you do not buy or sell previously owned glucose test strips, which can give incorrect results and may not be safe to use with your device. Talk to your…

FDA D.I.S.C.O.: FDA approval of Cablivi for acquired thrombotic thrombocytopenic purpura

FDA medical oncologists discuss the February 6, 2019, approval of caplacizumab-yhdp for acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy. Dr. Abhi Nair: Welcome back to the DISCO, FDA’s Drug Information Soundcast in Clinical Oncology from the Oncology Center of Excellence. We are based in Silver Spring, MD and during…

Confused by Date Labels on Packaged Foods?

Image CaptionThe phrase “Best if Used By” helps clarify that the date label is about quality, not safety, and that if stored properly, products do not necessarily have to be discarded after the date. Español Between the food industry and consumers, Americans are throwing out about a third of our food — about $161 billion…

E-cigarette: Safety Communication – Related to Seizures Reported Following E-cigarette Use, Particularly in Youth and Young Adults

[Posted 04/03/2019]  AUDIENCE: Consumers, Emergency Medicine, Health Professionals  ISSUE: The FDA has become aware that some people who use e-cigarettes have experienced seizures, with most reports involving youth or young adult users. Seizures or convulsions are known potential side effects of nicotine toxicity and have been reported in the scientific literature in relation to intentional…