Podcast Welcome back to the DISCO, 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. We’re back with a quick update on another recent FDA cancer drug approval. On March 10, 2021, the FDA approved tivozanib (brand name…
Former Dracut Nurse Sentenced for Tampering with Liquid Morphine
Department of JusticeU.S. Attorney’s OfficeDistrict of Massachusetts FOR IMMEDIATE RELEASEFriday, April 9, 2021 BOSTON – A former nurse was sentenced in federal court in Boston today for diverting liquid morphine intended for hospice patients at a Lowell nursing home. Michael Langlois, 50, of Dracut, was sentenced by U.S. Senior District Court Judge Mark L. Wolf to 42…
Voluntary Recall of Hostess® SnoBalls® Due to Undeclared Allergen
Summary Company Announcement Date: April 10, 2021 FDA Publish Date: April 10, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared coconut Company Name: Hostess Brands LLC Brand Name: Brand Name(s) Product Description: Product Description Company Announcement Hostess Brands, LLC (”Hostess Brands“) has become aware that certain Hostess® SnoBalls® were inadvertently…
Bit & Bet LLC Issues Voluntary Nationwide Recall of Thumbs Up 7 Blue 69K Due to Presence of Undeclared Sildenafil and Tadalafil
Summary Company Announcement Date: March 24, 2021 FDA Publish Date: March 30, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Sildenafil and Tadalafil Company Name: Bit & Bet LLC Brand Name: Brand Name(s) Thumbs Up 7 Product Description: Product Description Blue 69K Dietary Supplement for male sexual enhancement Company Announcement Bit &…
FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) for patients with metastatic or locally advanced esophageal or gastroesophageal carcinoma
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 be providing another quick update on a recent FDA cancer drug approval. On March 22, 2021, the FDA approved pembrolizumab (brand…
Medtronic Recalls Valiant Navion Thoracic Stent Graft System Due to Risk of Stent Fractures and Type III Endoleaks
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 Medtronic Valiant Navion Thoracic Stent Graft System Model Number, Product Codes, Catalog or Lot numbers: Please See Links Below. Distribution Dates: November 12, 2018 to February 10,…
NS NY Distributor Inc Issues Voluntary Nationwide Recall of Premium OrgaZen 7000 and Ginseng Power 5000 Due to Presence of Undeclared Sildenafil and/or Tadalafil
Summary Company Announcement Date: April 08, 2021 FDA Publish Date: April 09, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Sildenafil and/or Tadalafil Company Name: NS NY Distributor Inc Brand Name: Brand Name(s) NS NY Distributor Inc Product Description: Product Description Premium Orgazen 7000 and Ginseng Power 5000 capsules Company Announcement NS…
FDA D.I.S.C.O. Burst Edition: FDA approval of ABECMA (idecabtagene vicleucel) the first FDA approved cell-based gene therapy for the treatment of adult patients with 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 have another quick update on a recent FDA cancer therapeutic approval. On March 26, 2021, the FDA approved idecabtagene vicleucel (brand…
FDA Recommends Transition from Use of Decontaminated Disposable Respirators – Letter to Health Care Personnel and Facilities
April 9, 2021 The U.S. Food and Drug Administration (FDA) is recommending health care personnel and facilities transition away from crisis capacity conservation strategies, such as decontaminating or bioburden reducing disposable respirators for reuse. Based on the increased domestic supply of new respirators approved by the Centers for Disease Control and Prevention’s (CDC) National Institute…
FDA D.I.S.C.O. Burst Edition: Libtayo (cemiplimab-rwlc) for patients with locally advanced or metastatic basal cell carcinoma previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor (or an HHI) is not appropriate
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 another recent FDA cancer drug approval. On February 9, 2021, the FDA approved cemiplimab-rwlc (brand name…