FDA Novel Drugs
ZYCUBO FDA Approval: Survival Benefit in Menkes Disease
Generic Name: copper histidinate
- Brand Name: ZYCUBO
- Drug Class: Gene
- Sponsor by: Sentynl Therapeutics
- Approval Date: 12/01/2026
On January 12, 2026, the U.S. Food and Drug Administration (FDA) officially approved ZYCUBO® (copper histidinate) for injection, marking a historic achievement as the first and only approved treatment for
Author: Darshan Singh
Nereus (Tradipitant): A New Paradigm in the Pharmacologic Management of Motion-Induced Emesis
Generic Name: tradipitant
- Brand Name: NEREUS™.
- Drug Class: Others
- Sponsor by: Vanda Pharmaceuticals Inc.
- Approval Date: 30/12/2025
On December 30, 2025, the U.S. Food and Drug Administration (FDA) approved Nereus (tradipitant), an oral neurokinin-1 (NK-1) receptor antagonist, for the prevention of vomiting induced by motion in adults[1].
Author: Darshan Singh
Yartemlea (narsoplimab-wuug) FDA Approval: First-in-Class Survival Benefit for TA-TMA
Generic Name: narsoplimab-wuug
- Brand Name: YARTEMLEA
- Drug Class: MASP-2
- Sponsor by: Omeros Corporation
- Approval Date: 23/12/2025
On December 23, 2025, the U.S. Food and Drug Administration (FDA) approved Yartemlea (narsoplimab-wuug), a novel MASP-2 inhibitor developed by Omeros Corporation. This marks a significant regulatory milestone as Yartemlea