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…
Weis Markets Issues an Allergy Alert for Weis Quality Premium Sea Salt and Caramel Ripple Ice Cream Due to Undeclared Soy and Coconut Allergens
Summary Company Announcement Date: November 23, 2022 FDA Publish Date: November 23, 2022 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared Soy and Coconut Allergens Company Name: Weis Markets Brand Name: Brand Name(s) Weis Quality Product Description: Product Description Premium Sea Salt and Caramel Ripple Ice Cream Company Announcement Sunbury, PA…
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,…
Doctor Sentenced for Accepting Illegal Kickback Payments in Return for Writing Prescriptions for Compounded Drugs, Will Pay $3.1 Million in Civil Settlement
Department of JusticeEastern District of Virginia FOR IMMEDIATE RELEASEFriday, November 18, 2022 ALEXANDRIA, Va. – A doctor licensed in Virginia, Maryland, and elsewhere was sentenced today to 3 years for writing and referring compounded drug prescriptions in return for illegal kickback payments. The doctor previously entered into a civil settlement with the Government that requires him…
Elizabeth Holmes Sentenced to More Than 11 Years for Defrauding Theranos Investors of Hundreds of Millions
Department of JusticeNorthern District of California FOR IMMEDIATE RELEASEFriday, November 18, 2022 SAN JOSE – Elizabeth A. Holmes was sentenced today to 135 months (11 years, 3 months) in federal prison for defrauding investors in Theranos, Inc. of hundreds of millions of dollars, announced United States Attorney Stephanie M. Hinds, Federal Bureau of Investigation Special Agent…
Phil’s Power Pancake Issues Allergy Alert on Undeclared Wheat in Phil’s Power Pancake
Summary Company Announcement Date: November 17, 2022 FDA Publish Date: November 18, 2022 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared wheat Company Name: Phil’s Power Pancake Brand Name: Brand Name(s) Phil’s Power Pancake Product Description: Product Description Pancakes in 5 varieties (mango, raspberry, cranberry, dates, chocolate chip hempseed Company Announcement…
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…
Green Day Produce, Inc. Recalls Enoki Mushrooms Because of Possible Health Risk
Summary Company Announcement Date: November 17, 2022 FDA Publish Date: November 17, 2022 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential to be contaminated with Listeria Monocytogenes Company Name: Green Day Produce Brand Name: Brand Name(s) Green Day Produce Product Description: Product Description Enoki Mushrooms Company Announcement Green Day Produce, Inc….