fda

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

Muronomab (Orthoclone OKT3) made history as the first FDA-approved monoclonal antibody. Biointron reviews its impact on immunotherapy and antibody drug development.

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.

Explore the top 10 FDA-approved antibody drugs in 2023, including Humira, Keytruda, and Rituxan, and learn how Biointron supports antibody drug discovery and development.

Explore the top FDA-approved antibody drugs from 1980-2022, including Humira, Keytruda, and Herceptin, their development history, and uses in cancer and autoimmune diseases.

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.