Rhapsido (remibrutinib) in one screen Rhapsido is an oral Bruton’s tyrosine kinase (BTK) inhibitor approved by the US FDA on 30 September 2025 for chronic spontaneous urticaria (CSU) in adults who stay symptomatic on H1 antihistamines. It is the first…
Reviewed and updated: 12 August 2026. Regulatory status, indications and Indian commercial-availability status change frequently. Verify against the primary sources in the References before making any clinical, procurement or regulatory decision. In brief Datopotamab deruxtecan is a TROP2-directed antibody-drug conjugate…
Live regulatory tracker · CDER novel approvals FDA New Drug List 2026: Novel Drug Approvals and Key Insights Every new molecular entity and new therapeutic biologic cleared by FDA’s Center for Drug Evaluation and Research in 2026, with sponsor, modality,…
MYQORZO (aficamten) represents a significant advancement in the management of obstructive hypertrophic cardiomyopathy (oHCM), a condition characterized by thickened heart muscle that obstructs blood flow out of the heart. Approved by the FDA in December 2025, it provides a targeted…
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…
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…