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. Today we’ll provide a quick update on two recent FDA cancer drug approvals. On January 15, 2021, FDA approved fam-trastuzumab deruxtecan-nxki (brand name…
Medtronic Perfusion Systems Recalls Bio-Console 560 Extracorporeal Blood Pumping Console for Possible Electrical Failure Causing the Pump to Stop
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 Bio-Console 560 Extracorporeal Blood Pumping Console (Bio-Console 560) Models: 560BC, 560BCS, 560BC1, 560BCS1, R560BCS1 Serial Numbers: Please See Links Below. Distribution Dates: April 1, 2019 to…
Lo que debe saber sobre el cáncer colorrectal
Image English El año pasado, en los Estados Unidos, se diagnosticó a más de 136,000 personas con cáncer colorrectal, y más de 50,000 murieron a causa de esta enfermedad, según el Instituto Nacional del Cáncer. El cáncer colorrectal es la segunda causa de muerte relacionada con el cáncer en los Estados Unidos, y algunos grupos…
FDA D.I.S.C.O. Burst Edition: Tepmetko (tepotinib) and Ukoniq (umbralisib)
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 two recent FDA cancer drug approvals. On February 3, 2021, the FDA granted accelerated approval to…
BD Announces the Voluntary Recall of Specified Lots of ChloraPrep™ Hi-Lite Orange™ 26 mL Applicator in the United States and U.S. Territories Due to Defective Applicator
Summary Company Announcement Date: April 20, 2021 FDA Publish Date: April 20, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Defective applicator Company Name: Becton, Dickinson and Company Brand Name: Brand Name(s) ChloraPrep Product Description: Product Description ChloraPrep™ Hi-Lite Orange™ 26 mL Applicator Company Announcement BD (Becton, Dickinson and Company), a leading global…
Colorectal Cancer: What You Should Know About Screening
Image The evidence is clear – screening for colorectal cancer may save your life. Today, more and more people are choosing colorectal cancer screening. As a result, there is a steady decline in the number of older people getting and dying from colorectal cancer. Lower rates of smoking among Americans have also contributed to the…
Tenacore Recalls Alaris Pump Bezel Assembly and Alaris Infusion Pumps repaired with Bezel Assembly Due to Possible Cracked or Separated Bezel Repair Posts
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 Alaris Infusion Pumps serviced by Tenacore Models: Model 8100 Serial Numbers: Please See Link Below. Distribution Dates: July 10, 2020 to February 18, 2021 Devices Recalled in…
FDA D.I.S.C.O. Burst Edition: Breyanzi (lisocabtagene maraleucel)
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…
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…
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…