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…
For an Indian formulation plant, “USFDA approval roadmap” essentially means that both your facility and your products meet United States Food and Drug Administration requirements for quality, safety, and compliance with current Good Manufacturing Practice (cGMP) under 21 CFR Parts…
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,…
Overview Wegovy (semaglutide) is a long‑acting GLP‑1 receptor agonist available as a once‑weekly subcutaneous injection and a once‑daily high‑dose oral tablet. It is approved to reduce major adverse cardiovascular events in adults with established cardiovascular disease and obesity or overweight,…
Diabetes is a global epidemic – in 2022 about 14% of adults had the disease (up from 7% in 1990). It causes serious complications (heart attack, stroke, kidney failure) and over 2 million deaths each year. New therapies are urgently needed.…
The FDA establishes rigorous microbiological and chemical standards for high-purity water systems used in pharmaceutical manufacturing. These standards are fundamental to ensuring the safety, efficacy, and sterility of drug products, regardless of whether they are produced domestically or internationally. Water…
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…