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  2. List of drugs granted breakthrough therapy designation

    en.wikipedia.org/wiki/List_of_drugs_granted...

    In combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant ...

  3. Fast track (FDA) - Wikipedia

    en.wikipedia.org/wiki/Fast_track_(FDA)

    Once a drug receives fast track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.

  4. List of therapeutic monoclonal antibodies - Wikipedia

    en.wikipedia.org/wiki/List_of_therapeutic...

    This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage. See the list of FDA-approved therapeutic monoclonal antibodies in the monoclonal antibody therapy page.

  5. FDA Grants Fast Track Designation for Cubist's Late-Stage ...

    www.aol.com/news/2013-05-07-fda-grants-fast...

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  6. On the Fast Track to FDA Approval - AOL

    www.aol.com/news/2012-09-19-on-the-fast-track-to...

    Editor's note: A previous version of this article erroneously referred to Sarepta and Tekmira's drugs as vaccines, and mentioned that MAP Pharmaceuticals was developing an Ebola therapy. The Fool ...

  7. Spectrum's (SPPI) NSCLC Drug Gets FDA's Fast Track ... - AOL

    www.aol.com/news/spectrums-sppi-nsclc-drug-gets...

    The FDA grants a Fast Track designation to Spectrum Pharmaceuticals' (SPPI) poziotinib for treating non-small cell lung cancer in previously treated patients with HER2 exon 20 mutations.

  8. List of largest selling pharmaceutical products - Wikipedia

    en.wikipedia.org/wiki/List_of_largest_selling...

    Drug Main indication Trade name 2018 sales (million USD) 2017 sales (million USD) 1 adalimumab: rheumatoid arthritis: Humira 19 936 18427 3 apixaban: anticoagulant: Eliquis 9872 7395 4 lenalidomide: multiple myeloma: Revlimid 9685 8187 5 nivolumab: oncology: Opdivo 7570 5763 6 pembrolizumab: oncology: Keytruda 7171 3809 7 etanercept: rheumatoid ...

  9. Breakthrough therapy - Wikipedia

    en.wikipedia.org/wiki/Breakthrough_therapy

    A breakthrough therapy designation can be assigned to a drug if "it is a drug which is intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition" and if the preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as ...

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