mercoledì, 18 settembre 2024

Notizie AIOM – anno XVIII

19 Dicembre 2019

FDA Panel Supports Pembrolizumab for High-Risk NMIBC

December 17, 2019 - The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 9 to 4 supporting the approval of a new drug application (NDA) for pembrolizumab for the treatment of patients with Bacillus Calmette-Guerin (BCG)–unresponsive, high-risk, non-muscle ...
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19 Dicembre 2019

Statement on low-cost biosimilar and interchangeable protein products

December 17, 2019 - Ensuring an efficient pathway to bring potentially lower-cost biosimilar and interchangeable protein products to market is key for expanding access to these products and increasing competition, ultimately helping American patients. In March 2020 most ...
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19 Dicembre 2019

FDA Grants Priority Review to Encorafenib/Cetuximab Combo for BRAF+ mCRC

December 18, 2019 - The FDA has granted a priority review designation to a supplemental new drug application (sNDA) for the combination of encorafenib and cetuximab as a treatment for patients with advanced BRAF V600E–mutant metastatic colorectal cancer (mCRC) following ...
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