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  2. List of drugs granted breakthrough therapy designation

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

    In combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adults with locally advanced or metastatic non- small cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test [2]

  3. ClinicalTrials.gov - Wikipedia

    en.wikipedia.org/wiki/ClinicalTrials.gov

    The Food and Drug Administration Modernization Act of 1997 (Public Act 105-115) [4] amended the Food, Drug and Cosmetic Act and the Public Health Service Act to require that the NIH create and operate a public information resource, which came to be called ClinicalTrials.gov, tracking drug efficacy studies resulting from approved Investigational ...

  4. National drug code - Wikipedia

    en.wikipedia.org/wiki/National_Drug_Code

    The national drug code (NDC) is a unique product identifier used in the United States for drugs intended for human use. The Drug Listing Act of 1972 [ 1 ] [ 2 ] requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared, propagated, compounded, or processed ...

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list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage.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

  6. FDA-approved drug for ulcerative colitis also effective for ...

    www.aol.com/fda-approved-drug-ulcerative-colitis...

    Mirikizumab, a drug currently approved by the Food and Drug Administration (FDA) for the treatment of ulcerative colitis, also sends Crohn's disease into clinical remission, new findings suggest.

  7. List of withdrawn drugs - Wikipedia

    en.wikipedia.org/wiki/List_of_withdrawn_drugs

    Still used as veterinary drug and as a human antihelminthic in many markets; listed on the WHO List of Essential Medicines. In humans, it was used to treat melanoma before it was withdrawn for agranulocytosis. [29] [30] [31] Levomethadyl acetate: 2003 US Cardiac arrhythmias and cardiac arrest. [2] Lorcaserin (Belviq) 2020 US Increased risk of ...

  8. Approved drug - Wikipedia

    en.wikipedia.org/wiki/Approved_drug

    Before a drug can be prescribed, it must undergo the FDA's approval process. While a drug can feasibly be used off-label (for non-approved indications), it still is required to be approved for a specific disease or medical condition. [2] Drug companies seeking to sell a drug in the United States must first test it.

  9. Investigational New Drug - Wikipedia

    en.wikipedia.org/wiki/Investigational_new_drug

    The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.

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