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…

    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…

    Lebanon County Man Sentenced to Seventy Months’ Imprisonment for Trafficking Counterfeit Drugs

    Department of JusticeU.S. Attorney’s OfficeDistrict of Pennsylvania FOR IMMEDIATE RELEASEThursday, April 15, 2021 HARRISBURG – The United States Attorney’s Office for the Middle District of Pennsylvania announced that Stefen Knoche, age 55, of Lebanon, Pennsylvania, was sentenced today to 70 months’ imprisonment by U.S. District Court Judge Sylvia H. Rambo for trafficking in counterfeit drugs. Knoche was…

    Blount Fine Foods Voluntarily Recalls a Limited Amount (a Single Lot) of Lobster Bisque Due to Possible Undeclared Egg Allergen

    Summary Company Announcement Date: April 14, 2021 FDA Publish Date: April 15, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared egg Company Name: Blount Fine Foods Brand Name: Brand Name(s) Product Description: Product Description Lobster Bisque Company Announcement Blount Fine Foods announced that, in partnership with the FDA, it is…

    Jose Madrid Salsa Issues a Voluntary Recall Due to an Undeclared Anchovy Allergen

    Summary Company Announcement Date: April 14, 2021 FDA Publish Date: April 15, 2021 Product Type: Food & Beverages Gravy/Sauces Allergens Reason for Announcement: Recall Reason Description Undeclared anchovy Company Name: Jose Madrid Salsa Brand Name: Brand Name(s) Jose Madrid Salsa Product Description: Product Description Strawberry Mild Salsa Company Announcement Jose Madrid Salsa in Zanesville, Ohio…

    Lake Champlain Chocolates Voluntarily Recalls Mr. Goodtime Bunny With Best By Date 11/20/2021 for Undeclared Almonds

    Summary Company Announcement Date: April 15, 2021 FDA Publish Date: April 15, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared almonds Company Name: Lake Champlain Chocolates Brand Name: Brand Name(s) Mr. Goodtime Bunny Product Description: Product Description Chocolate candy Company Announcement Lake Champlain Chocolates (LCC) is issuing a public alert…