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  1. Antibody therapeutics approved or in regulatory review in the EU or US

    The Antibody Society maintains a comprehensive list of approved antibody therapeutics and those in regulatory review in the European Union (EU) or United States (US). In the table below, product …

  2. List of therapeutic monoclonal antibodies - Wikipedia

    This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate …

  3. FDA has approved 119 therapeutic mAbs (including two diagnostic mAb).[1] Among them, in 2015, FDA approved 10 therapeutic monoclonal antibodies;[2] it was a historic high since the first approval in 1992.

  4. Biological Approvals by Year | FDA

    Jun 2, 2025 · A collection of biological approval information organized by year and regulatory authorities.

  5. FDA Approvals | mAb - Purdue University

    Note: these approvals are sourced from Drugs@FDA and Purple Book, and do not currently reflect older FDA approvals and/or other evidence of US marketing.

  6. Table of monoclonal antibodies with a valid marketing authorisation ...

    Nov 18, 2025 · The list of medicines contains the products that have a valid marketing authorization. It contains no information as to whether the preparations are available on the market.

  7. 2020 FDA/EMA approvals for new immunotherapy drug technologies …

    This review gives an overview of new immunotherapeutic products approved by FDA/EMA in 2020. Moreover, the technologies used in manufacturing monoclonal antibodies (mAbs), antibody-drug …

  8. Antibody therapeutics product data - The Antibody Society

    Antibody therapeutics product data The Antibody Society continuously collects data for approved antibody therapeutics and those in regulatory review in any country. A searchable table of this data is …

  9. Compilation of CDER New Molecular Entity (NME) Drug and New …

    This dataset provides a listing of all New Molecular Entities (NMEs) approved from 1985 – 2019 and regulated by the Center for Drug Evaluation and Research (CDER).

  10. Drug Approvals and Databases | FDA

    Sep 24, 2025 · Web page provides quick links to everything from acronyms to wholesale distributor and third-party logistics providers reporting. Additional topics include: approved REMS, drug shortages, …