Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide another quick update on a recent FDA cancer drug approval. On November 10, 2022, the FDA approved tremelimumab (brand name…
Update on Endologix AFX Endovascular AAA Graft Systems and Risk of Type III Endoleak: FDA Safety Communication
Date Issued: December 6, 2022 The U.S. Food and Drug Administration (FDA) is updating our January 2022 safety communication on the use of Endologix AFX endovascular grafts used to treat patients with abdominal aortic aneurysm (AAA). On December 6, 2022, the FDA approved new labeling for the currently available product, the AFX2 Endovascular AAA System…
Former Malden Firefighter Sentenced for Distributing Controlled Substances
Department of JusticeDistrict of Massachusetts FOR IMMEDIATE RELEASETuesday, December 6, 2022 BOSTON – A former Malden firefighter was sentenced yesterday in federal court in Boston for conspiring to distribute controlled substances including oxycodone, suboxone, Klonopin and Adderall. Joshua Eisnor, 43, of North Reading, was sentenced by U.S. District Court Judge Leo T. Sorokin to five years…
Cranberry Sweets & More Issues Allergy Alert On Undeclared Peanuts In “Mint Meltaways”
Summary Company Announcement Date: December 06, 2022 FDA Publish Date: December 06, 2022 Product Type: Food & Beverages Chocolate/Cocoa Product Allergens Reason for Announcement: Recall Reason Description Potential or Undeclared Allergen/Peanut Company Name: Cranberry Sweets & More Brand Name: Brand Name(s) Cranberry Sweets Product Description: Product Description Mint Meltaways Company Announcement December 6, 2022, Cranberry…
FDA D.I.S.C.O. Burst Edition: FDA approval of Libtayo (cemiplimab-rwlc) in combination with platinum-based chemotherapy for non-small cell lung cancer
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide another quick update on a recent FDA cancer drug approval. On November 8, 2022, the FDA approved cemiplimab-rwlc (brand name…
UPDATE: Impella RP System Post-Approval Study Results and Updated Labeling – Letter to Health Care Providers
December 5, 2022 The U.S. Food and Drug Administration (FDA) is issuing this update to our previous letter to health care providers to inform the health care community of the final post-approval study (PAS) results and updated labeling for the Impella RP System manufactured by Abiomed. The final PAS results show that the survival rate…
Exportadora Copramar Recalls James Farms Frozen Raspberries Due to Possible Health Risk
Summary Company Announcement Date: December 03, 2022 FDA Publish Date: December 03, 2022 Product Type: Food & Beverages Fruit/Fruit Product Foodborne Illness Reason for Announcement: Recall Reason Description Hepatitis A Company Name: Exportadora Compramar Brand Name: Brand Name(s) James Farms Product Description: Product Description Frozen Raspberries Company Announcement Exportadora Copramar is recalling 1260 cases of…
Getinge Maquet/Datascope Intra-Aortic Balloon Pump (IABP) Shortage – Letter to Health Care Providers
December 2, 2022 The U.S. Food and Drug Administration (FDA) is alerting health care facilities and providers of a shortage of Getinge Maquet/Datascope Intra-Aortic Balloon Pump (IABP) devices, including limited supplies of IAB catheters, new Cardiosave IABPs, and Cardiosave IABP parts. Recommendations The FDA recommends that health care facilities and providers who use Getinge Maquet/Datascope…
Former Vice President and General Manager of New England Compounding Center Sentenced to Prison
Department of JusticeDistrict of Massachusetts FOR IMMEDIATE RELEASEThursday, December 1, 2022 BOSTON – A former co-owner of the now-defunct New England Compounding Center (NECC) was sentenced today in federal court in Boston in connection with conspiring to defraud the Food and Drug Administration (FDA). Gregory Conigliaro, 57, of Southborough, Mass. was sentenced by U.S. District Court…
Comunicado de seguridad de la FDA: reutilice las cánulas de traqueostomía o cambie a alternativas adecuadas durante su escasez
Fecha de emisión: 31 de octubre de 2022 La Administración de Alimentos y Medicamentos de los Estados Unidos (FDA) está alertando a los pacientes, cuidadores y proveedores de atención médica acerca de una escasez de cánulas de traqueostomía, incluidas las cánulas de traqueostomía Bivona fabricadas por ICU Medical. Es más probable que la escasez de…