August 2025– date –

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...

■ Introduction In July 2025, the prestigious journal Science officially retracted a paper it had published in 2010, claiming the discovery of a bacterium that could substitute arsenic for phosphorus in its DNA. Known as the “arsenic life...

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...