Tag: FDA biosimilars

Biosimilar Approval: How the FDA Reviews Biologic Alternatives in 2026

Biosimilar Approval: How the FDA Reviews Biologic Alternatives in 2026
wayne Holloway in: Medications 16 January 2026

The FDA's 2025 guidance streamlines biosimilar approval by replacing costly clinical trials with advanced analytical data, accelerating access to lower-cost biologic alternatives for cancer, arthritis, and diabetes. Learn how the process works and what's still holding it back.

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Statin-Related Liver Problems: What Elevated Liver Enzymes Really Mean
Statin-Related Liver Problems: What Elevated Liver Enzymes Really Mean

Statin-related liver enzyme elevations are common but rarely dangerous. Learn when to worry, when to ignore, and why stopping your statin over a lab result could put your heart at risk.

Published ON: 2 Feb
Polycystic Kidney Disease: Understanding the Genetic Disorder and How to Manage It
Polycystic Kidney Disease: Understanding the Genetic Disorder and How to Manage It

Polycystic kidney disease is a genetic disorder causing cysts to grow in the kidneys, leading to kidney failure. Learn how ADPKD and ARPKD work, how to manage symptoms, and what new treatments are on the horizon.

Published ON: 7 Feb
Hyponatremia and Hypernatremia in Kidney Disease: What You Need to Know
Hyponatremia and Hypernatremia in Kidney Disease: What You Need to Know

Hyponatremia and hypernatremia are common, dangerous complications in kidney disease. Learn how sodium imbalances happen, why standard treatments fail, and what actually works to protect your health.

Published ON: 8 Feb
How to Track Post-Marketing Studies for Drug Safety
How to Track Post-Marketing Studies for Drug Safety

Learn how post-marketing studies track drug safety after approval, using FAERS, Sentinel, and real-world data to catch hidden risks. Understand the systems, challenges, and future of pharmacovigilance.

Published ON: 11 Feb
Team-Based Care: How Multidisciplinary Teams Are Changing Generic Prescribing
Team-Based Care: How Multidisciplinary Teams Are Changing Generic Prescribing

Team-based care transforms how generic drugs are prescribed by bringing together doctors, pharmacists, and nurses to improve safety, adherence, and cost savings - especially for patients with multiple chronic conditions.

Published ON: 18 Feb

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