At the recent CBER agency workshop on cell therapies and tissue-based products, a few surprising ideas discussed could have ...

*题图来自网络FDA计划基于最新安全性数据修订CAR-T细胞疗法的继发性恶性肿瘤风险警告。与此同时，行业呼吁简化治疗标签要求，以扩大患者可及性，并探索CAR-T在自身免疫疾病等新适应症中的应用潜力。FDA警告声明调整：几经波折，未来可期生物制品评价与 ...

The recommendations were made in a closed session with representatives from CBER, the CDC and Department of Defense.

Capricor Therapeutics announced that the U.S. FDA has accepted its Biologics License Application (BLA) for deramiocel, aimed at treating cardiomyopathy in patients with Duchenne muscular dystrophy ...