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Key priority drugs were approved to treat cancers like lung cancer and melanoma, as well as hepatitis c and lupus Our report showcases the new therapies we evaluated for safety and eficacy, as well as important regulatory tools we used to expedite the review and approval of these applications. Archive of previously approved medications that have gained new fda approval for the treatment of additional medical conditions.
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This list includes novel new drugs, known as new molecular entities (nmes), biologics and new indications for drugs already approved Seven newly sanctioned medications provided advances in cancer treatment, and 10 were for orphan diseases The list below includes the nmes approved by cder in calendar year 2011
Fda's center for biologics evaluation and research (cber) approves biological drugs
At the end of fiscal year 2011, fda examined the combined drug approvals of both cder and cber for fy 2011 (see report). In a report released today, fy 2011 innovative drug approvals, the fda provided details of how it used expedited approval authorities, flexibility in clinical trial requirements and.
