Miers Laboratories, Ltd – 715378 – 11/03/2025
CGMP/Finished Pharmaceuticals/Adulterated
Taizhou Kangping Medical Science and Technology Co., Ltd. – 711081 – 10/09/2025
CGMP/Finished Pharmaceuticals/Adulterated
IBSPOT.com Inc. – 715657 – 10/27/2025
Unapproved New Drugs/Misbranded
FDA Requests Labeling Changes Related to Safety Information to Clarify the Benefit/Risk Considerations for Menopausal Hormone Therapies
Proposed removal of risk statements about cardiovascular diseases, breast cancer, and probable dementia from the boxed warnings, as well as…
Konrad Rejdak, MD, PhD – 671405 – 05/01/2025
Bioresearch Monitoring Program/IRB
FDA approves daratumumab and hyaluronidase-fihj for high-risk smoldering multiple myeloma
On November 6, 2025, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) for adults…
How to Prepare a Pre-Request for Designation (Pre-RFD)
Guidance for Industry: How to Prepare a Pre-Request for Designation (Pre-RFD)
Glowface – 11/03/2025
Unapproved New Drugs/Misbranded/Botox
Derma Solution – 11/03/2025
Unapproved New Drugs/Misbranded/Botox
MJS Medicals – 11/03/2025
Unapproved New Drugs/Misbranded/Botox