The Medicines and Healthcare products Regulatory Agency (MHRA) enforces pharmaceutical manufacturing standards across the United Kingdom through a principles-based, risk-managed regulatory framework aligned with international Good Manufacturing Practice (GMP). This guide provides manufacturers, Quality Assurance professionals, and regulatory affairs teams…
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…
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…