drug_approval

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).

The approval of Eli Lilly’s Kisunla (donanemab-azbt), a humanized IgG1 monoclonal antibody, is just one of the major advancements in the treatment of Alzheimer's disease (AD)! This drug is now available in the US for adults with early symptomatic AD, including those with mild cognitive impairment (MCI) and mild dementia stage of AD with amyloid pathology.

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.

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

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.