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…
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…
In pharmaceutical manufacturing, aseptic processing control is the distinct methodology used to produce sterile drug products that cannot be terminally sterilized due to thermal instability. Unlike terminal sterilization, which destroys microorganisms in the final sealed container, aseptic processing relies on…
As the pharmaceutical landscape becomes increasingly complex, the US Food and Drug Administration (USFDA) has definitively shifted from a purely reactive, punitive compliance model to a proactive, risk-based oversight framework. This strategic evolution, championed by the principles of ICH Q9…
As the pharmaceutical landscape evolves, so too does the rigor of the U.S. Food and Drug Administration’s (FDA) oversight. The Pre-Approval Inspection (PAI) e.g. USFDA PAI checklist remains the critical gatekeeper, serving two primary objectives: to verify the authenticity and…