FDA medical oncologists discuss the agency’s March 2017 approval of niraparib for the maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Transcript: Sanjeeve Bala: Welcome to the DISCO. Abhi Nair: This is Abhi Nair, medical officer at the Oncology…
5 Things to Know About Breast Implants
Español Should I get breast implants? Are there alternatives? Will they need to be replaced? And if I decide to get implants, which are medical devices, there are even more questions. Saline or silicone? Which style? Implants with a smooth surface or a textured surface? How much monitoring is needed? These are common questions people…
FDA D.I.S.C.O.: First Tissue/Site Agnostic Approval Transcript
The D.I.S.C.O. hosts discuss the agency’s first approval of a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated. Transcript: Sanjeeve Bala: Welcome back to the D.I.S.C.O. Today’s Drug Information Soundcast in Clinical Oncology from FDA’s Oncology Center of Excellence covers the accelerated approval of pembrolizumab,…
La FDA acelera la innovación en la creación de terapias para las enfermedades raras
English Con frecuencia, los pacientes necesitan de alguien que interceda por ellos, y esto puede ser especialmente cierto para las personas que padecen una enfermedad rara, quienes enfrentan problemas únicos y tal vez tengan poco o ningún apoyo o tratamiento disponibles. La Administración de Alimentos y Medicamentos (FDA, por sus siglas en inglés) está comprometida…
FDA Speeds Innovation in Rare Disease Therapies
Español Patients often need advocates, and that can be especially true for people with a rare disease, who have unique problems and may have little or no support or available treatment. The Food and Drug Administration (FDA) is committed to helping patients and advancing rare disease therapies through the development of “orphan” medical products, including…
FDA D.I.S.C.O.: Avelumab in Merkel Cell Carcinoma Transcript
FDA medical oncologists discuss the agency’s March 23, 2017, approval of avelumab the treatment of patients 12 years and older with metastatic Merkel cell carcinoma. Transcript: Sanjeeve Bala: Once again, welcome to the D.I.S.C.O. Today’s Drug Information Soundcast in Clinical Oncology from FDA’s Oncology Center of Excellence will focus on the recent approval of avelumab,…
5 Tips for Traveling to the U.S. With Medications
Español You’re returning from a trip overseas and want to bring back over-the-counter drugs from Europe that aren’t available here. Can you? Your mother-in-law is visiting from Mexico to help with the new baby and runs out of her blood pressure medication. Can she refill her prescription at a U.S. pharmacy? Your foreign exchange student…
FDA D.I.S.C.O.: Two approvals for ALK-positive non-small cell lung cancer
FDA medical oncologists discuss the FDA approvals of brigatinib and ceritinib for ALK-positive non-small cell lung cancer. Transcript: Sanjeeve Bala: Welcome back to the DISCO. Today’s Drug Information Soundcast in Clinical Oncology from FDA’s Oncology Center of Excellence discusses two recent approvals: brigatinib, marketed as ALUNBRIG™, and ceritinib marketed as ZYKADIA®. I’m Sanjeeve Bala, a…
Cinco consejos para viajar a los Estados Unidos con medicamentos
English Usted viene de regreso de un viaje en el extranjero y quiere traer medicamentos de venta sin receta de Europa que no están disponibles aquí. ¿Puede hacerlo? Su suegra está de visita de México para ayudarla con su nuevo bebé y se le acaba la medicina para la presión arterial. ¿Puede surtir su receta…
FDA D.I.S.C.O.: Osimertinib for Non-Small Cell Lung Cancer
FDA medical oncologists discuss the approval of osimertinib for EGFR mutation-positive non-small cell lung cancer. Transcript: Sanjeeve Bala: Welcome back to the D.I.S.C.O. Today’s Drug Information Soundcast in Clinical Oncology from FDA’s Oncology Center of Excellence discusses the recent approval of osimertinib, marketed as TAGRISSO. Abhi Nair: Around 10 to 15 percent of patients with…