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…
Starting a pharmaceutical manufacturing plant in India requires a carefully planned capital investment that varies significantly based on plant type, production capacity, and regulatory requirements. A basic domestic-focused tablet or capsule plant requires ₹5-15 crores minimum, while a mid-scale operation…
ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate—the five fundamental data integrity principles established by the FDA in the 1990s to ensure pharmaceutical data quality and regulatory compliance. These principles form the cornerstone of Good Documentation Practices (GDP) and…
Tablet compression machines, also known as tablet presses, are precision pharmaceutical manufacturing equipment designed to transform carefully formulated powders or granulated materials into tablets of uniform size, shape, weight, and hardness. These machines operate according to Pascal’s Law and the principles of hydraulic…
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…
In pharmaceutical manufacturing, selecting a tablet compression machine that meets USFDA and EU GMP standards ensures consistent tablet quality, high throughput, and seamless regulatory compliance. These top five models—Fette Compacting FE55, Korsch AG XL 400 (4th Generation), GEA NexGen Press…