FDA Novel Drugs
Generic Name: Difamilast
- Brand Name: Adquey
- Drug Class: Small molecule
- Sponsor by: Otsuka Pharmaceutical
- Approval Date: 12/02/2026
On February 12, 2026, the U.S. Food and Drug Administration (FDA) approved the New Drug Application (NDA) for ADQUEY™ (difamilast 1%) ointment for the topical treatment of mild-to-moderate atopic dermatitis
Author: Darshan Singh
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
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
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