Dec. 2 Regulatory Roundup: Chipscreen’s approval; plus Priority Review for new Imfinzi, Keytruda indications; EMA reviewing Orchard, Amarin candidates; and more

A spate of regulatory news since the start of the Thanksgiving holiday included a drug approval for Chipscreen, a duo of Priority Reviews from FDA, a pair of EMA reviews, and the scheduling of two advisory committee meetings to review a total of four applications.

China’s National Medical Products Administration extended the label of HDAC inhibitor Epidaza chidamide to treat advanced or metastatic breast cancer in hormone receptor-positive, HER2-negative, postmenopausal patients who relapsed or progressed after endocrine therapy. Shenzhen Chipscreen Biosciences Ltd. (Shanghai:688321) launched the drug in 2015 for its first approved indication, peripheral T cell lymphoma...