Therapeutics– tag –

In July 2025, the FDA began publishing past Complete Response Letters (CRLs). Triangulating those releases with company disclosures and primary reporting shows two dominant themes: CMC (quality/manufacturing/testing) & Pre-License In...

In this final volume, we summarize the latest developments in bispecific antibody drug R&D by leading biotech and pharma companies, as well as major approvals over the past year in the US and EU. We also highlight key trends and nota...

Even among bispecific antibody drugs, the pharmacological behavior in the body can vary significantly depending on the structural modality. This article explains in simple terms how differences in modalities—such as IgG-based, non-IgG, a...

On August 8, 2025, the U.S. Food and Drug Administration (FDA) granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals, Inc.), a kinase inhibitor, for adults with unresectable or metastatic non-squamo...

On August 6, 2025, the U.S. Food and Drug Administration (FDA) granted accelerated approval to dordaviprone (Modeyso, Jazz Pharmaceuticals), a protease activator, for adult and pediatric patients (≥1 year) with progressive H3 K27M-mutant...

In this third installment of our Beginner-Friendly Bispecific Antibody Drug series, we delve into the crucial question: “Which targets should be selected?” Target selection is a core strategic decision in bispecific antibody development,...

In this second installment of our series on bispecific antibody drugs, we delve into the diverse structural formats that define the field. From tandem scFvs to full-length IgG-like structures, we examine how these formats affect function...

Introduction: Why Are Bispecific Antibody Drugs Gaining Attention? In recent years, bispecific antibody drugs (BsAbs) have garnered increasing attention in the treatment of cancer, autoimmune diseases, and infectious diseases. By binding...

Why do some people develop diabetes while others with similar lifestyles don’t?The answer may lie in your molecular fingerprint. This article summarizes groundbreaking findings from a recent Cell (July 2025) paper and integrates insights...

Fierce Biotech's "Layoff Tracker 2025" has captured a wave of downsizing across the U.S. biotech landscape in the first half of 2025. This article breaks down key layoffs, underlying causes, industry categories impacted, and what this mi...

Global Strategies Shaping the Future of in vivo CAR-T Development Throughout this series, we have explored the cutting-edge developments of in vivo CAR-T therapy in an accessible way for beginners. In this final installment, we will exam...

Key Figures Shaping the Future of in vivo CAR-T This series aims to provide a clear and accessible overview of the latest advancements in in vivo CAR-T therapies, especially for beginners. In Part 7, we focus on the global researchers, e...

In vivo CAR-T therapy has rapidly emerged as a promising next-generation cancer treatment. However, realizing its full potential requires overcoming several hurdles: targeting only the desired cells, ensuring safety, and maintaining sust...

For in vivo CAR-T cells to attack cancer persistently and effectively, the structure of the CAR itself is critical. In particular, the design of co-stimulatory molecules and intracellular signaling domains directly impacts the treatment'...

In this third installment of our introductory series on in vivo CAR-T, we focus on a vital component for realizing safe and effective therapy: the design of CAR expression. We explore how “smart control” of CAR expression—targeting tumor...

In the first installment of our series, we introduced the revolutionary CAR-T cell therapy through the moving story of Emily Whitehead. This time, we take a deep dive into the underlying technologies that make “in vivo CAR-T” possible. F...

CAR-T cell therapy has emerged as a groundbreaking treatment that specifically targets cancer cells. Among its forms, the “in vivo type” CAR-T—where the therapeutic process happens inside the body—is gaining attention as a next-generatio...

Over the past few years, the landscape of Antibody-Drug Conjugates (ADCs) has undergone a dramatic transformation, shifting from a niche therapeutic approach to a central pillar of oncology innovation. This bonus chapter highlights recen...

Antibody-drug conjugates (ADCs) deliver highly potent cytotoxic agents specifically to cancer cells, representing a breakthrough in targeted therapy. This article explains the final stage of ADC function—how the linker system releases th...

In Antibody-Drug Conjugates (ADCs), antibodies serve as targeting agents that deliver drugs to cancer cells. This article focuses on the "Variable Region," the key structure that enables antibodies to specifically recognize cancer antige...