Reviewed and updated: 4 July 2026. Regulatory approval status, indications, and India commercial-availability status can change. Verify current status against the primary sources in the References section before making clinical, procurement, or regulatory decisions. In brief: Datopotamab deruxtecan-dlnk is a…
This page provides a consolidated and continuously updated overview of FDA novel drug approvals in 2026, covering pharmaceutical products that receive first-time approval in the United States during the calendar year. Unlike the official FDA listing, which presents approvals in…
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On December 12, 2025, the U.S. Food and Drug Administration (FDA) approved Lerochol (lerodalcibep-liga), a novel third-generation proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor developed by LIB Therapeutics, Inc. Lerochol is approved as an adjunct to diet and exercise to…
HYRNUO® (sevabertinib), a reversible tyrosine kinase inhibitor targeting HER2 (ERBB2), received FDA approval on November 19, 2025, under the accelerated approval pathway for a molecularly defined population of lung cancer patients [Approval Letter, November 19, 2025, Reference ID: 5698585]. This approval…
This post provides a consolidated and structured overview of FDA novel drug approvals in 2025, covering pharmaceutical products that received first-time approval in the United States during the calendar year. Unlike the official listings published by the FDA, this page…
On November 25, 2025, the U.S. Food and Drug Administration (FDA) granted accelerated approval to VOYXACT (sibeprenlimab-szsi), a novel biologic therapy for adults with primary immunoglobulin A nephropathy (IgAN)[3]. Developed by Otsuka Pharmaceutical Company, Ltd., this approval marks a significant…
Rhapsido (remibrutinib) represents a significant advancement in chronic spontaneous urticaria (CSU) management following Rhapsido FDA approval on September 30, 2025. This first-in-class oral Bruton’s tyrosine kinase (BTK) inhibitor addresses a critical clinical gap for the estimated 1-2 million CSU patients failing…
Acromegaly, a rare endocrine disorder caused by excess growth hormone (GH), has posed immense challenges in clinical management. For decades, patients with inadequate surgical response or inoperable cases relied on complex regimens of injectable somatostatin analogs. PALSONIFY (paltusotine), newly approved…
The landscape of endocrine therapy for hormone receptor-positive (HR+) breast cancer continues to evolve rapidly, particularly for patients whose disease has become resistant to standard-of-care treatments. On September 25, 2025, the FDA approved INLURIYO (imlunestrant) tablets, a new oral selective…