The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development
The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development
Biosimilars Action Plan
FDA is committed to encouraging innovation and competition for biologics and facilitating the development of safe and effective biosimilars.
Aurora Pharmaceutical – 698797 – 02/07/2025
False & Misleading Claims/Misbranded
Elanco Animal Health – 695170 – 01/28/2025
False & Misleading Claims/Misbranded
FDA approves pembrolizumab and berahyaluronidase alfa-pmph for subcutaneous injection
On September 19, 2025, the Food and Drug Administration approved pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) for subcutaneous injection…
Frequently Asked Questions about Drug Shortages
This page answers frequently asked questions (FAQ) about drug shortages such as what is a drug shortage, how many per…
Bulk Drug Substances Used in Compounding
Compounders sometimes produce drugs using bulk drug substances or active pharmaceutical ingredients. Because compounding from these substances presents risks to…
Identification of Candidate Biomarkers Detected in the Urine of Racehorses After Anabolic Agent Administration: Use of Orthogonal Methods for Structural Elucidation
Potential biomarkers revealed by a metabolomics study were identified in racehorse urine, using chemical and biochemical orthogonal methods, for anabolic…
Identification of Candidate Biomarkers Detected in the Urine of Racehorses After Anabolic Agent Administration: Use of Orthogonal Methods for Structural Elucidation
Potential biomarkers revealed by a metabolomics study were identified in racehorse urine, using chemical and biochemical orthogonal methods, for anabolic…
Primal Herbs Volume may be harmful due to hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use Primal Herbs Volume, a product promoted and…