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 a quick update on another recent FDA cancer drug approval. On August 25, 2021, FDA approved ivosidenib (brand name Tibsovo)…
Janus Kinase (JAK) inhibitors: Drug Safety Communication – FDA Requires Warnings about Increased Risk of Serious Heart-related Events, Cancer, Blood Clots, and Death
AUDIENCE: Patient, Rheumatology, Gastroenterology, Cardiology, Neurology, Oncology, Pharmacy, Health Professional ISSUE: The FDA is requiring revisions to the Boxed Warning, FDA’s most prominent warning, for Xeljanz/Xeljanz XR (tofacitinib), Olumiant (baricitinib) and Rinvoq (upadacitinib) to include information about the risks of serious heart-related events, cancer, blood clots, and death. Based on the review of a large randomized safety…
Weis Markets Issues an Allergy Alert for $7 Crab Cake Meal Due to Undeclared Milk Allergen
Summary Company Announcement Date: September 02, 2021 FDA Publish Date: September 02, 2021 Product Type: Food & Beverages Shellfish Allergens Reason for Announcement: Recall Reason Description Undeclared milk Company Name: Weis Markets Brand Name: Brand Name(s) Weis Markets Product Description: Product Description Crab Cake Meal Company Announcement Weis Markets today announced it has issued a…
Magellan Diagnostics, Inc. Expands Voluntary Recall of LeadCare® Test Kits
Summary Company Announcement Date: September 01, 2021 FDA Publish Date: September 02, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description LeadCare Test Kits lots could potentially underestimate blood lead levels when processing patient blood samples Company Name: Meridian Bioscience, Inc. Brand Name: Brand Name(s) Meridian Bioscience, Inc. Product Description: Product Description LeadCare®…
The Baking Institute Bakery Co. Issues Allergen Alert on Undeclared Walnuts, Coconuts and Milk in “Carrot Cake”
Summary Company Announcement Date: September 02, 2021 FDA Publish Date: September 02, 2021 Product Type: Food & Beverages Bakery Product/Mix Allergens Reason for Announcement: Recall Reason Description Undeclared walnuts, coconuts and milk Company Name: Nicotine Nirvana Brand Name: Brand Name(s) The Baking Institute Bakery Co. Product Description: Product Description Carrot Cake Company Announcement The Baking…
Berwick Man Charged with Conspiring to Manufacture and Distribute Anabolic Steroids
Department of JusticeU.S. Attorney’s OfficeMiddle District of Pennsylvania FOR IMMEDIATE RELEASEWednesday, August 25, 2021 SCRANTON- The United States Attorney’s Office for the Middle District of Pennsylvania announced that Casey Seesholtz, age 31, of Berwick, Pennsylvania, was charged in a criminal information with conspiring to manufacture and distribute anabolic steroids. Seesholtz was charged on August 27,…
North Carolina Man Ran Lucrative Fraud Scheme Selling Unapproved Substances that Mimic the Health Benefits of Legal Drugs
Department of JusticeU.S. Attorney’s OfficeWestern District of Pennsylvania FOR IMMEDIATE RELEASETuesday, August 31, 2021 PITTSBURGH, PA – A resident of North Carolina pleaded guilty in federal court to a charge of conspiracy to defraud the United States, Acting United States Attorney Stephen R. Kaufman announced today. Joshua Fulton, 41, Bolivia, North Carolina, pleaded guilty to…
KBF Inc. Issues Allergy Alert on Undeclared Milk Allergens in Banoful Top Orange Biscuit
Summary Company Announcement Date: August 25, 2021 FDA Publish Date: August 31, 2021 Product Type: Food & Beverages Snack Food Item Allergens Reason for Announcement: Recall Reason Description Undeclared milk Company Name: KBF Inc. Brand Name: Brand Name(s) Product Description: Product Description Banoful Top Orange Biscuit Company Announcement KBF Inc. of Astoria, NY, is recalling…
Hearing Aids and Personal Sound Amplifiers: Know the Difference
You’ve likely seen them advertised on television—small electronic sound amplifiers that allow users to enjoy nighttime TV without disturbing sleepers, or to hear their toddlers from many yards away. While these personal sound amplifiers may help people hear things that are at low volume or at a distance, the Food and Drug Administration (FDA) wants…
FDA D.I.S.C.O. Burst Edition: FDA approvals of Jemperli (dostarlimab-gxly) for patients with mismatch repair deficient recurrent or advanced solid tumors, and Opdivo (nivolumab) for the adjuvant treatment of patients with urothelial 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 provide a quick update on two recent FDA cancer drug approvals. On August 17, 2021, the FDA approved dostarlimab-gxly (brand name…