Hepatitis B virus (HBV) infection is a major global health issue, driven by high levels of immunosuppressive viral antigens, the host immune system's failure to effectively control the virus, and the immunosuppressive environment of the liver. Existing therapies have limited effectiveness in eliminating the hepatitis B surface antigen (HBsAg).

Blood disorders, including anemias, coagulopathies, leukemias, lymphomas, and thrombocytopenias, disrupt the normal functioning of blood components. Antibody therapeutics, such as monoclonal antibodies (mAbs), have transformed treatment approaches by offering targeted, high-specificity interventions.

Intravenous immunoglobulins (IVIGs) offer a versatile treatment modality for a variety of immune-mediated disorders. Originally used for antibody replacement therapy, their unexpected anti-inflammatory and immunomodulatory effects have allowed them to extend their use to

ADCs for ES-SCLC. Image credit: DOI: 10.3390/genes15060701Extensive-stage small-cell lung cancer (ES-SCLC) is a particularly aggressive form of lung cancer characterized by rapid growth and early metastasis. Antibody drugs, especially immune checkpoint inhibitors, have emerged as a promising treatme

ムロノマブ-CD3（商品名：オーソクローン OKT3）は、1986年に米国食品医薬品局（FDA）によってヒト使用が承認された最初のモノクローナル抗体として、歴史的に重要です。

The development and approval of novel antibody drugs represent a significant segment of pharmaceutical innovation, addressing a wide range of diseases from cancer to autoimmune disorders. Since the first monoclonal antibody (mAb) drug was approved in 1986, there has been explosive growth in this area. By 2021, the US FDA had approved its 100th mAb product, with mAbs now accounting for nearly a fifth of the agency’s new drug approvals each year.

2023年にFDA（米国食品医薬品局）が承認した抗体医薬品トップ10について、以下にリストをまとめます。このリストは、FDAの公式発表や関連資料に基づいており、臨床的重要性、新規性、または注目度を考慮して選出されています。なお、提供された情報に基づき、2023年に承認されたモノクローナル抗体および二重特異性抗体を中心に記載します。

抗体医薬は、さまざまな疾患に対する治療薬としてますます重要なクラスとなっています。本記事では、1980年から2022年までに規制当局によって承認されたトップ10の抗体医薬を紹介し、それぞれの開発の歴史や治療対象となる疾患についての情報を提供します。

Research into treatments for Alzheimer's disease (AD) has reached impressive milestones this year.

The last few decades have witnessed an acceleration in the discovery and development of therapeutic antibodies.

Respiratory syncytial virus (RSV) has recently gained much attention due to the approval of several drugs this year.On May 3, 2023, the U.S. Food and Drug Administration (FDA) authorized Arexvy, the first RSV vaccine for use in the United States.