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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 List of withdrawn drugs - Wikipedia

    en.wikipedia.org/wiki/List_of_withdrawn_drugs

    Cardiac valvular disease, pulmonary hypertension, cardiac fibrosis; [3] [23] re-approved in June 2020 for the treatment of seizures associated with Dravet syndrome, under FDA orphan drug rules. Fenoterol: 1990 New Zealand Asthma mortality. [3] Feprazone: 1984 Germany, UK Cutaneous reaction, multiorgan toxicity. [3] Fipexide: 1991 France ...

  4. Complete Response Letter - Wikipedia

    en.wikipedia.org/wiki/Complete_Response_Letter

    In United States pharmaceutical regulatory practice, a Complete Response Letter (CRL), or more rarely, a 314.110 letter, is a regulatory action by the Food and Drug Administration in response to a New Drug Application, Amended New Drug Application or Biologics License Application, indicating that the application will not be approved in its present form. [1]

  5. New Pancreatic Cancer Drug an FDA Priority - AOL

    www.aol.com/2013/05/26/new-pancreatic-cancer...

    The FDA has granted Celgene's abraxane priority review as a first-line treatment for advanced pancreatic cancer, a move that shortens the normal review period by four months. In this video, health ...

  6. Priority review - Wikipedia

    en.wikipedia.org/wiki/Priority_review

    The statute authorizes the FDA to award a priority review voucher to the sponsor (manufacturer) of a newly approved drug or biologic that targets a neglected tropical disease or a rare pediatric disease. The provision applies to New Drug Applications (NDAs), Biological License Applications (BLAs) and 505(b)(2) applications. The voucher, which ...

  7. The FDA has recalled thousands of bottles of the antidepressant duloxetine, sold under brand name Cymbalta, due to the presence of a possibly cancer-causing chemical.

  8. 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.

  9. Regeneron's blood cancer therapy faces setback as FDA ... - AOL

    www.aol.com/news/regenerons-blood-cancer-therapy...

    (Reuters) -Regeneron Pharmaceuticals said on Monday the U.S. FDA has declined approval for its blood cancer therapy for two forms of lymphoma on concerns over the progress of ongoing confirmatory ...

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