Record Date: 08/7/2025
Entity Name: Sumitomo Pharma Co., Ltd.
FEI Number: 3003028650
Record Type: 483
Country: Japan
Establishment Type: Drug Manufacturer
Similar Posts
Everlaan Organics, Inc. dba Maple Organics – 707956 – 08/11/2025
CGMP/OTC/Unapproved New Drugs/MisbrandedFDA Public Workshop: Future Needs for the Development of Interchangeable Products – 09/19/2025
The public meeting will be held on September 19, 2025, from 9 a.m. to 1 p.m. The meeting agenda, federal register notice, additional materials, and any other updates will also be posted to this website as they become available.Patient-Focused Drug Development
The OCE PFDD program fosters collaboration between FDA centers and external stakeholders involved in patient outcomes research in cancer populations.FDA approves mitomycin intravesical solution for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer
On June 12, 2025, the Food and Drug Administration approved mitomycin intravesical solution (Zusduri, UroGen Pharma) for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).FDA removes risk evaluation and mitigation strategy (REMS) program for the antipsychotic drug Clozapine
FDA removes risk evaluation and mitigation strategy (REMS) program for the antipsychotic drug ClozapineInfant Breathing System Recall: AirLife/Vyaire Removes Infant Heated Wire Circuits Due to Risk for Inadvertent Adapter Disconnection During Ventilation
AirLife Infant Heated Wire Circuits heat up gas during ventilation. An included adapter may disconnect when the device reaches operating temperature.