Musclepower Enterprise Ltd. dba MONSTER KING and GE LABS – 719339 – 12/12/2025
Unapproved New Drugs/Misbranded
Sklar Personal Care Inc. – 716656 – 12/09/2025
CGMP/Finished Pharmaceuticals/Adulterated
FDA approves drug for type of abnormally fast heart rhythm
The U.S. Food and Drug Administration (FDA) has approved Cardamyst (etripamil) nasal spray to treat episodes of paroxysmal supraventricular tachycardia…
FDA approves fam-trastuzumab deruxtecan-nxki with pertuzumab for unresectable or metastatic HER2-positive breast cancer
On December 15, 2025, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) in combination with pertuzumab…
Zoliflodacin – Oral Products
Zoliflodacin – Oral Products
Enhancing Participation in Clinical Trials — Eligibility Criteria, Enrollment Practices, and Trial Designs
This guidance recommends approaches that sponsors of clinical trials intended to support a new drug application or a biologics license…
Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs
This guidance recommends approaches that sponsors of clinical trials intended to support a new drug application or a biologics license…
Environmental Impact Review at CDER
OPS Environmental Impact Review at CDER: ENVIRONMENTAL IMPACT: CLAIMS FOR CATEGORICAL EXCLUSION
Sponsor Responsibilities – Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies
Sponsor Responsibilities – Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies
