Tag: National Medical Products Administration
China’s NMPA expands AstraZeneca’s Forxiga use as heart failure treatment
China's National Medical Products Administration (NMPA) has approved AstraZeneca's Forxiga (dapagliflozin) for diminishing the risk of cardiovascular fatalities and hospitalizations in adults diagnosed with symptomatic ... Read More
AstraZeneca, Daiichi Sankyo’s Enhertu approved for breast cancer in China
The National Medical Products Administration (NMPA) of China has granted approval to AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for use as a monotherapy in ... Read More
Gufic Biosciences secures NMPA approval to market Prilocaine (API) in China
Gufic Biosciences has received approval from the National Medical Products Administration (NMPA) in China for its product, Prilocaine (API), an amide-type local anesthetic. The approval ... Read More
Innovent Biologics’ olverembatinib gets Chinese breakthrough therapy status in SDH-deficient GIST
Innovent Biologics has been granted breakthrough therapy designation (BTD) for olverembatinib from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). ... Read More
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 ... Read More
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 ... Read More
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). ... Read More