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  2. Belimumab - Wikipedia

    en.wikipedia.org/wiki/Belimumab

    Belimumab is primarily used in people with systemic lupus erythematosus. When it was introduced in 2011, it was the first new drug approved to treat lupus in 56 years. [8] Sales rose to $31.2 million in the first quarter of 2012. [37] The total cost for the first year of treatment with belimumab is $28,000. [38]

  3. 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 ...

  4. Timeline of human vaccines - Wikipedia

    en.wikipedia.org/wiki/Timeline_of_human_vaccines

    2003 – First nasal influenza vaccine approved in U.S. 2003 – First vaccine for Argentine hemorrhagic fever. [16] 2006 – First vaccine for human papillomavirus (which is a cause of cervical cancer) 2006 – First herpes zoster vaccine for shingles; 2011 – First vaccine for non-small-cell lung carcinoma (comprises 85% of lung cancer cases)

  5. Roche's Gazyva Now a Breakthrough Therapy for Lupus Nephritis

    www.aol.com/news/roches-gazyva-now-breakthrough...

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  6. Fast track (FDA) - Wikipedia

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

    Fast track is a designation by the United States Food and Drug Administration (FDA) of an investigational drug for expedited review to facilitate development of drugs that treat a serious or life-threatening condition and fill an unmet medical need. Fast track designation must be requested by the drug company.

  7. Priority review - Wikipedia

    en.wikipedia.org/wiki/Priority_review

    Prior to approval, each drug marketed in the United States must go through a detailed FDA review process. In 1992, under the Prescription Drug User Fee Act (PDUFA), FDA agreed to specific goals for improving the drug review time and created a two-tiered system of review times – standard review and priority review.

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