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  2. Approved Drug Products with Therapeutic Equivalence ...

    en.wikipedia.org/wiki/Approved_Drug_Products...

    Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced by the United States Food and Drug Administration (FDA), as required by the Drug Price and Competition Act (Hatch-Waxman Act). The Hatch-Waxman Act was created to '"strike a balance between two competing policy interests:

  3. Prescription drug prices in the United States - Wikipedia

    en.wikipedia.org/wiki/Prescription_drug_prices...

    The FDA has a "priority review process" for drugs which compete with another drug whose price exceeds its value-based price. Congress could also grant the FDA the ability to change the exclusivity period for new drugs. [6] The FDA could also temporarily allow the import of drugs approved for sale outside the United States. [65]

  4. Zanubrutinib - Wikipedia

    en.wikipedia.org/wiki/Zanubrutinib

    The U.S. Food and Drug Administration (FDA) granted zanubrutinib priority review, accelerated approval, breakthrough therapy, and orphan drug designations. [ 10 ] [ 15 ] [ 23 ] The FDA approved zanubrutinib in November 2019, and granted the application for Brukinsa to BeiGene USA Inc. [ 10 ] [ 15 ] [ 24 ]

  5. Tucatinib - Wikipedia

    en.wikipedia.org/wiki/Tucatinib

    In January 2023, the US Food and Drug Administration (FDA) granted accelerated approval to tucatinib in combination with trastuzumab for RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. [12]

  6. PD-1 and PD-L1 inhibitors - Wikipedia

    en.wikipedia.org/wiki/PD-1_and_PD-L1_inhibitors

    Micrograph showing a PD-L1 positive lung adenocarcinoma.Positive immunostaining can predict response to the treatment.. PD-1 inhibitors and PD-L1 inhibitors are a group of checkpoint inhibitor anticancer drugs that block the activity of PD-1 and PDL1 immune checkpoint proteins present on the surface of cells.

  7. Bexarotene - Wikipedia

    en.wikipedia.org/wiki/Bexarotene

    Bexarotene, sold under the brand Targretin, is an antineoplastic (anti-cancer) agent used for the treatment of cutaneous T cell lymphoma (CTCL). [4] It is a third-generation retinoid. [5] It was approved by the U.S. Food and Drug Administration (FDA) in December 1999, and the European Medicines Agency (EMA) in March 2001.

  8. Binimetinib - Wikipedia

    en.wikipedia.org/wiki/Binimetinib

    In June 2018, it was approved for the treatment of certain melanomas by the U.S. Food and Drug Administration (FDA) in combination with encorafenib. [6] The FDA approved binimetinib based primarily on evidence from one clinical trial (NCT01909453) of 383 patients with BRAF V600 mutation-positive melanoma that was advanced or could not be ...

  9. Asciminib - Wikipedia

    en.wikipedia.org/wiki/Asciminib

    The US Food and Drug Administration (FDA) granted the application for asciminib priority review, fast track, orphan drug, and breakthrough therapy designations. [ 7 ] [ 20 ] [ 21 ] [ 22 ] In July 2024, the US Food and Drug Administration (FDA) granted priority review designation to asciminib for the treatment of newly diagnosed adults with ...

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