This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications with postmarketing trials that have verified clinical benefit and for which traditional approval has been subsequently granted for the specific indication.
Similar Posts
POSTPONED – 17th Annual Sentinel Initiative Public Workshop – 11/06/2025
The U.S. Food and Drug Administration, under a cooperative agreement with the Duke-Margolis Institute for Health Policy, is hosting the 16th Annual Sentinel Initiative Public Workshop on November 6, 2025Wells Pharmacy LLC. Dyersburg, TN. Untitled Letter issued 10/14/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 10/14/2025
Short Title (70 char) Wells Pharmacy LLC. Dyersburg, TN. Untitled Letter issued 10/14/2025
FEI Number 3011761321
Firm Name Wells Pharmacy LLC
Record Type Untitled Letter
State TN
Establishment Type OuAbdallah Candies Issues a Voluntary Recall of Pecan Caramel Clusters Due to Undeclared, Mislabeled Allergens
Abdallah Candies is voluntarily recalling a specific lot of Pecan Caramel Clusters, due to a mislabeled allergen. Product contains Cashews that were not listed on the product label. Product was sold and distributed exclusively to Lunds & Byerlys, as a private label, sold in the state of Minnesota.Inotiv Inc. – 10/24/2025
Inotiv Inc. – 10/24/2025. Country: United States. Record Type: 483FDA Approves Expanded Use of Vonvendi for von Willebrand Disease, Including for Certain Uses for Children
The U.S. Food and Drug Administration today approved expanded use of Vonvendi [von Willebrand factor (Recombinant)] for routine preventative (prophylactic) use in adults (age 18 years and older) with all types of von Willebrand disease (VWD) and on-demand and treatment of bleeding episodes and perioAstellas Pharma Inc. – 06/06/2025
Astellas Pharma Inc. – 06/06/2025. Country: Japan. Record Type: 483