强生的Tecvayli+Darzalex Faspro联合治疗凭借在MajesTEC-3试验中的积极数据(3年PFS率83% vs 对照组30%),获FDA优先审评券(CNRV)FDA修改RWE政策,允许医疗器械上市申请中使用去标识化的数据集。FDA批准两款新药:第三代 PCSK9 抑制剂 Lerochol和速效钙通道阻滞剂Cardamyst,并批准Enhertu用于乳腺癌一线治疗。12月15日,...
Source Link强生的Tecvayli+Darzalex Faspro联合治疗凭借在MajesTEC-3试验中的积极数据(3年PFS率83% vs 对照组30%),获FDA优先审评券(CNRV)FDA修改RWE政策,允许医疗器械上市申请中使用去标识化的数据集。FDA批准两款新药:第三代 PCSK9 抑制剂 Lerochol和速效钙通道阻滞剂Cardamyst,并批准Enhertu用于乳腺癌一线治疗。12月15日,...
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