Home » Posts tagged with » National Medical Products Administration
AstraZeneca scores Chinese approval for heart failure therapy Forxiga

AstraZeneca scores Chinese approval for heart failure therapy Forxiga

AstraZeneca said that Forxiga (dapagliflozin) has secured approval in China for its use in the reduction of the risk of cardiovascular (CV) death and hospitalization for heart failure (hHF) in adults having heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF). The approval for the sodium-glucose co-transporter 2 inhibitor (SGLT2 inhibitor) from the Chinese […]

Amgen gets breakthrough therapy status for sotorasib in China

Amgen said that sotorasib, an investigational KRASG12C inhibitor, has been given breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. The Chinese breakthrough therapy designation for sotorasib is for the treatment of patients having KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer […]

Continue reading …
Antengene gets NMPA nod for eltanexor phase 1/2 clinical trial in myelodysplastic syndrome

Antengene has been given approval from China’s National Medical Products Administration (NMPA) for a phase 1/2 clinical trial of ATG-016 (eltanexor) in myelodysplastic syndrome (MDS). The Chinese biopharma company will enroll patients having intermediate and higher risk myelodysplastic syndrome as determined by the Revised International Prognostic Scoring System (IPSS-R) after the failure of hypomethylating agents […]

Continue reading …