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Antengene Submits New Drug Application for Selinexor in Taiwan for the Treatment of Three Indications in Hematologic Malignancies


Antengene Submits New Drug Application for Selinexor in Taiwan for the Treatment of Three Indications in Hematologic Malignancies
-In July 2019, selinexor (XPOVIO®) was approved by the U.S. FDA and became the first and only XPO1 inhibitor indicated for the treatment of hematologic malignancies.
-Selinexor has been approved in the U.S., Israel, UK, and EU countries.
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SHANGHAI and HONG KONG, July 13, 2021 /PRNewswire/ Antengene Corporation Limited ( Antengene , SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, today announced that it has submitted a New Drug Application (NDA) to the Taiwan Food and Drug Administration (TFDA) for selinexor, a first-in-class XPO1 inhibitor, for three indications: in combination with bortezomib and dexamethasone (XVd) ....

New Zealand , South Korea , Kevin Lynch , Jay Mei , Asia Pacific , Karyopharm Therapeutics Inc , Antengene Corporation , European Commission , Drug Administration , China National Medical Products Administration , Prnewswire Antengene Corporation Limited , Antengene Corporation Limited , Connective Tissue Oncology Society , Israeli Ministry Of Health , Ministry Of Food , Corporation Limited , New Drug Application , Taiwan Food , New Drug Applications , Priority Review , National Medical Products Administration , Orphan Drug Designation , Drug Safety , Chief Medical Officer , Karyopharm Therapeutics , Greater China ,

Antengene Announces Acceptance of IND Application in China for the Phase II Clinical Trial of Single-Agent Selinexor for the Treatment of Myelofibrosis (MF)


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SHANGHAI and HONG KONG, July 5, 2021 /PRNewswire/ Antengene Corporation Limited ( Antengene , SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, recently announced that China s National Medical Products Administration (NMPA) has accepted the Investigational New Drug (IND) application for single agent selinexor, a first-in-class orally available Exportin 1 (XPO1) inhibitor, for the treatment of patients with myelofibrosis (MF) in China.
MF is a clonal hematologic neoplasm which can emerge either as primary MF, polycythemia vera (PV) or essential thrombocythemia (ET)
[1]. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is currently the only curative treatment for MF. However, such treatment is difficult to carry out and has a low rate of success. According to the ....

New Zealand , South Korea , Jay Mei , Asia Pacific , S El Jamal , Karyopharm Therapeutics Inc , Antengene Corporation , European Commission , Drug Administration , China National Medical Products Administration , Prnewswire Antengene Corporation Limited , Antengene Corporation Limited , Connective Tissue Oncology Society , Israeli Ministry Of Health , Ministry Of Food , National Comprehensive Cancer Network , Corporation Limited , National Medical Products Administration , Investigational New Drug , Karyopharm Therapeutics , Greater China , Israeli Ministry , Safety Monitoring Board , New Drug Applications , Priority Review , Orphan Drug Designation ,

Antengene to study selinexor in Phase II trial for myelofibrosis

Antengene to study selinexor in Phase II trial for myelofibrosis
clinicaltrialsarena.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from clinicaltrialsarena.com Daily Mail and Mail on Sunday newspapers.

South Korea , Jay Mei , China National Medical Products Administration , European Commission , Ministry Of Food , National Medical Products Administration , Drug Safety , தெற்கு கொரியா , ஜெய் மெய் , ஐரோப்பிய தரகு , அமைச்சகம் ஆஃப் உணவு , மருந்து பாதுகாப்பு ,