Tag: biologic alternatives

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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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
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
Edema in CKD: How Diuretics, Salt Restriction, and Compression Therapy Work Together
Edema in CKD: How Diuretics, Salt Restriction, and Compression Therapy Work Together

Edema in CKD is caused by fluid buildup from failing kidneys. Managing it requires a three-part strategy: the right diuretics, strict salt restriction, and compression therapy. Learn how each works-and how to use them safely.

Published ON: 7 Feb
How the FDA Ensures Generic Drug Quality During Manufacturing
How the FDA Ensures Generic Drug Quality During Manufacturing

Discover how the FDA maintains strict quality standards for generic drugs through cGMP regulations, unannounced inspections, and rigorous testing. Learn about the five key control areas, global comparisons, and real-world impact on drug safety and affordability.

Published ON: 4 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

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