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 therapeutic approval. On February 5, 2021, the FDA approved lisocabtagene maraleucel (brand…
Shearer’s Foods LLC Issues Allergy Alert on Undeclared Milk in Raley’s Salt & Vinegar Flavored Potato Chips
Summary Company Announcement Date: April 19, 2021 FDA Publish Date: April 19, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description May Contain Undeclared Milk Company Name: Shearer’s Foods LLC Brand Name: Brand Name(s) Product Description: Product Description Salt & Vinegar Flavored Potato Chips Company Announcement Shearer’s Foods LLC of Massillon, OH…
FDA D.I.S.C.O. Burst Edition: Libtayo (cemiplimab-rwlc) for first-line treatment of patients with advanced NSCLC (locally advanced who are not candidates for surgical resection or definitive chemoradiation or metastatic) whose tumors have high PD-L1 expression with no eGFR, anaplastic lymphoma kinase or receptor tyrosine kinase aberrations
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 drug approval. On February 22, 2021, the FDA approved cemiplimab-rwlc (brand name…
Creative Foods Inc Issues Allergy Alert on Undeclared Hazelnut, Peanut And Barley (Gluten) In Two Coffee Substitute Gluten-Free Products
Summary Company Announcement Date: April 17, 2021 FDA Publish Date: April 17, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared peanut, hazelnut, and/or barley (gluten) Company Name: Creative Foods Inc. Brand Name: Brand Name(s) Product Description: Product Description Coffee substitute Company Announcement Creative Foods Inc. of Prineville, Oregon is recalling…
FDA D.I.S.C.O. Burst: Approval of Pepaxto (melphalan flufenamide) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received at least four lines of prior therapy
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 drug approval. On February 26, 2021, the FDA granted approval to melphalan…
CareFusion 303, Inc. Recalls BD Alaris Pump Module Model 8100 Due to Risk of Stuck or Unresponsive Keys
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 BD Alaris Infusion Pump Module Affected Model Number: 8100 Affected Parts: 49000239; 49000346; 49000438; 49000439 Manufacturing Dates: 01/15/2019 to 12/05/2019. Distribution Dates: January 23, 2019 to December…
FDA D.I.S.C.O. Burst Edition: FDA approvals of Erbitux (cetuximab) for K-Ras wild type, EGFR-expressing colorectal cancer or squamous cell carcinoma of the head and neck and Trodelvy (sacituzumab govitecan) for patients with unresectable locally advanced or metastatic triple negative breast cancer
Podcast Welcome 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. Today we have an update on two recent FDA cancer drug approvals. On April 6, 2021, FDA approved a new dosage regimen of 500…
Durisan Announces a Voluntary Recall Expansion of its Antimicrobial Hand Sanitizer
Summary Company Announcement Date: April 10, 2021 FDA Publish Date: April 16, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Product is contaminated with Burkholderia contaminans Company Name: Sanit Technologies LLC d/b/a Durisan Brand Name: Brand Name(s) Product Description: Product Description Hand sanitizer Company Announcement Sanit Technologies LLC d/b/a Durisan announces a voluntary…
Medtronic Recalls HeartWare HVAD Battery Cables, Data Cables, Adapter Cables and Controller 2.0 Ports Due to Risk of Damage to Controller Ports
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 HeartWare HVAD Battery Cables, Data Cables, Adapter Cables and Controller 2.0 Ports Product Numbers: Medtronic HVAD Controller AC Adapter: 1425AU, 1425CA, 1425DE, 1425GB, 1425IL, 1425IT, 1425US, 1430AR,…
FDA D.I.S.C.O. Burst Edition: Lorbrena (lorlatinib) for patients with metastatic non-small cell lung cancer whose tumors are anaplastic lymphoma kinase-positive, detected by an FDA-approved test
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 3, 2021, the FDA granted regular approval…