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FDA accepts for priority review a Daiichi Sankyo and AstraZeneca supplemental BLA for Enhertu (fam-trastuzumab deruxtecan-nxki) fo...[ Price : $8.95]
FDA releases a draft guidance on the expanded use of remote regulatory assessments beyond the Covid-19 pandemic to assess an FDA-r...[ Price : $8.95]
Federal Register notice: FDA withdraws approval of three NDAs from multiple holders because they repeatedly failed to file require...[ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Eli Lillys Tauvid (flortauc...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Real-Time Oncology Review (RTOR) that provides recommendati...[ Price : $8.95]
CDER director Patrizia Cavazzoni tells Friends of Cancer Research that the potential use of circulating tumor DNA as an endpoint t...[ Price : $8.95]
FDA releases a final guidance entitled Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe.[ Price : $8.95]
FDA posts a final guidance entitled Orange Book Questions and Answers that answers commonly asked questions it has received from i...