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RSS FeedPosted by Michael Wonder on 22 Nov 2022
Junshi Biosciences announces approval of supplemental application for additional indications of adalimumab injection
22 November 2022 - Shanghai Junshi Biosciences announced today that the supplemental application for additional indications of adalimumab injection (UBP1211) for ...
Posted by Michael Wonder on 18 Nov 2022
Calliditas' partner Everest Medicine's new drug application for Nefecon is accepted by the China NMPA
15 November 2022 - Calliditas Therapeutics today announced that the Chinese regulatory authority NMPA has accepted Everest Medicines' new drug application ...
Posted by Michael Wonder on 02 Nov 2022
Henlius' novel anti-PD-1 mAb Hansizhuang (serplulimab) receives NMPA approval for the treatment of sqNSCLC
1 November 2022 - Shanghai Henlius Biotech announced that its first self-developed innovative anti-PD-1 monoclonal antibody Hansizhuang (serplulimab), in combination with ...
Posted by Michael Wonder on 21 Oct 2022
Akeso's ivonescimab granted breakthrough therapy designation by China NMPA for the treatment of advanced NSCLC
20 October 2022 - Akeso announced that the Center for Drug Evaluation of China NMPA has granted breakthrough therapy designation ...
Posted by Michael Wonder on 18 Oct 2022
CARsgen announces NDA acceptance of BCMA CAR T zevor-cel (CT053) by China NMPA
18 October 2022 - CARsgen Therapeutics announces that the NMPA of China has accepted the new drug application for zevorcabtagene autoleucel ...
Posted by Michael Wonder on 11 Oct 2022
The China NMPA approved Cyramza (ramucirumab) for the treatment in patients with hepatocellular carcinoma
9 October 2022 - Innovent Biologics is pleased to see that the NMPA of China has approved the supplemental new drug ...
Posted by Michael Wonder on 11 Oct 2022
JW Therapeutics announces NMPA approval of relmacabtagene autoleucel injection in patients with relapsed or refractory follicular lymphoma
11 October 2022 - JW Therapeutics announced that the NMPA of China has approved the supplemental new drug application for its ...
Posted by Michael Wonder on 10 Oct 2022
China NMPA approves selpercatinib for the treatment of patients with RET driven lung and thyroid cancers
9 October 2022 - Innovent Biologics is pleased to see that the NMPA of China has approved the new drug application ...
Posted by Michael Wonder on 28 Sep 2022
Toray receives approval from China’s NMPA for Careload to treat pulmonary arterial hypertension
28 September 2022 - Toray Industries announced today that it has received approval from China’s NMPA for Careload tablets to treat ...
Posted by Michael Wonder on 23 Sep 2022
Lynparza approved in China as first-line maintenance treatment with bevacizumab for HRD positive advanced ovarian cancer
22 September 2022 - One in two women with advanced ovarian cancer has an HRD positive tumour. ...
Posted by Michael Wonder on 20 Sep 2022
Junshi Biosciences receives NMPA approval of sNDA for toripalimab in combination with chemotherapy as first-line treatment for advanced non-squamous non-small-cell lung cancer
20 September 2022 - Sixth approved indication of toripalimab in China, bringing more treatment options to patients with advanced non-small-cell ...
Posted by Michael Wonder on 13 Sep 2022
CStone announces China’s NMPA has accepted and granted priority review to the supplemental new drug application for sugemalimab in the treatment of patients with relapsed or refractory extranodal natural killer/T-cell lymphoma
13 September 2022 - GEMSTONE-201 is the largest registrational clinical study of an anti-PD-(L)1 antibody reported so far in patients with ...
Posted by Michael Wonder on 08 Sep 2022
ViewRay announces China NMPA approval of its MRIdian MRI guided radiation therapy for cancer patients
7 September 2022 - This approval expands MRIdian's global reach and offers cancer patients a new radiation therapy option—MRIdian SMART. ...
Posted by Michael Wonder on 06 Sep 2022
InnoCare announces priority review of orelabrutinib for the treatment of relapsed or refractory marginal zone lymphoma by NMPA
6 September 2022 - InnoCare Pharma announced today that BTK inhibitor orelabrutinib has been granted priority review for the treatment of ...
Posted by Michael Wonder on 05 Sep 2022
Forxiga approved in China for the treatment of chronic kidney disease in patients at risk of progression with and without type 2 diabetes
5 September 2022 - Approval marks the first SGLT-2 inhibitor approved in China for chronic kidney disease in adult patients ...