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…
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…
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…
Exela Pharma Sciences, LLC Expands Voluntary Nationwide Recall of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL Vial, 20-Count Carton due to Vial Breakage UPDATED November 28, 2022
Summary Company Announcement Date: November 28, 2022 FDA Publish Date: November 29, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Vial Breakage Company Name: Exela Pharma Sciences, LLC Brand Name: Brand Name(s) Product Description: Product Description Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial Company Announcement FOR IMMEDIATE RELEASE – November 28,…
FDA D.I.S.C.O. Burst Edition: FDA approval of Lytgobi (futibatinib) for adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 gene fusions or other rearrangements
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 a quick update on a recent FDA cancer drug approval. On September 30, 2022, the FDA granted accelerated approval to…
FDA D.I.S.C.O. Burst Edition: FDA approvals of Imjudo (tremelimumab) in combination with durvalumab for unresectable hepatocellular carcinoma, and Tecvayli (teclistamab-cqyv) for relapsed or refractory multiple myeloma
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 a quick update on two recent FDA cancer drug approvals. On October 21, 2022, the FDA approved tremelimumab (brand name…
Baxter Hillrom Recalls WatchCare Incontinence Management System (IMS) for Risk of RF Interference with Nearby Medical Equipment
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Name: WatchCare Incontinence Management System (IMS) Product Models: P7900B Centrella Bed with WatchCare P00697901: Hospital Bed Accessory, WatchCare System for VersaCare Bed Rev. A-J P00697902: Hospital…
Prolia (denosumab) by Amgen: Drug Safety Communication – FDA Investigating Risk of Severe Hypocalcemia in Patients on Dialysis
[Posted 11/22/2022] AUDIENCE: Patient, Health Professional, Pharmacy ISSUE: The FDA is investigating the risk of severe hypocalcemia with serious outcomes, including hospitalization and death, in patients with advanced kidney disease on dialysis treated with the osteoporosis medicine Prolia (denosumab). FDA’s review of interim results from an ongoing safety study of Prolia suggests an increased risk of hypocalcemia,…
Exactitud y limitaciones de los pulsioxímetros: Comunicado de seguridad de la FDA
English 15 de septiembre de 2022: Aviso de reunión del Comité Asesor La FDA anunció una reunión virtual del Panel de Dispositivos de Anestesiología y Terapia Respiratoria del Comité Asesor de Dispositivos Médicos del CDRH (en inglés) el 1 de noviembre de 2022, de 9 a.m. a 6 p.m. hora del este. Para obtener más…