Shots: The company has received an FDA’s CRL declining the approval of roxadustat’s NDA to treat anemia of CKD The FDA has requested to conduct an additional clinical study of […]readmore
Tags : CKD
Shots: The companies collaborated to commercialize the first biosimilar Darbepoetin alpha in the GCC market for the treatment of anemia associated with chronic renal failure. The CKD biosimilar is currently […]readmore
Shots: The P-lll DAPA-CKD study involves the assessing of Farxiga (qd, 10 mg) + SOC vs PBO in 4304 patients with CKD stages 2-4 and elevated urinary albumin excretion, with/ […]readmore
Shots: Lotus to get an exclusive commercialization right of biosimilar Darbepoetin alfa in Taiwan and Southeast Asian markets The collaboration allows the Lotus to re-emphasize its focus on nephrology as […]readmore
Shots: The P-III program involves assessing of Roxadustat vs PBO and epoetin alfa in 9,000+ NDD and DD & ID patients in multiple studies conducted by AstraZeneca, FibroGen and Astellas […]readmore
Shots: The two P-III J01 & J03 studies involve assessing of Vadadustat vs darbepoetin alfa in 304 & 323 Japanese patients (non- dialysis dependent & dialysis dependent) with anemia due […]readmore