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list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage.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

  4. Guselkumab - Wikipedia

    en.wikipedia.org/wiki/Guselkumab

    In April 2018, guselkumab was approved in Japan for the treatment of psoriatic arthritis. [19] In July 2020, the FDA approved guselkumab as the first IL-23 inhibitor to treat active psoriatic arthritis (PsA). [20] [21] In September 2024, the FDA approved guselkumab for the treatment of moderately to severely active ulcerative colitis in adults. [9]

  5. Zanubrutinib - Wikipedia

    en.wikipedia.org/wiki/Zanubrutinib

    In January 2023, the US Food and Drug Administration (FDA) approved zanubrutinib for chronic lymphocytic leukemia or small lymphocytic lymphoma. [19] In March 2024, FDA granted accelerated approval to zanubrutinib, in combination with obinutuzumab, for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. [20] [21]

  6. New type of non-opioid pain medication approved by FDA - AOL

    www.aol.com/type-non-opioid-pain-medication...

    The U.S. Food and Drug Administration (FDA) approved Journavx (suzetrigine) oral tablets on Thursday as a first-in-class non-opioid analgesic to treat acute pain in adults.

  7. Adagrasib - Wikipedia

    en.wikipedia.org/wiki/Adagrasib

    In June 2024, the US FDA granted accelerated approval to adagrasib plus cetuximab for adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. [10] [11]

  8. Sotatercept - Wikipedia

    en.wikipedia.org/wiki/Sotatercept

    Sotatercept was approved for medical use in the United States in March 2024, [6] [11] [12] and in the European Union in August 2024. [ 7 ] [ 8 ] [ 13 ] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication .

  9. Lutetium (177Lu) oxodotreotide - Wikipedia

    en.wikipedia.org/wiki/Lutetium_(177Lu)_oxodotreotide

    The FDA granted the approval of Lutathera to Advanced Accelerator Applications. [ 6 ] In April 2024, the FDA approved 177 Lu dotatate for the treatment of children aged 12 years and older with somatostatin receptor-positive (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut ...

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