The EU regulator has approved FibroGen and Astellas Evrenzo for adults with anaemia caused by chronic kidney disease (CKD), just days after the FDA turned down the drug in the US.
The FDA has demanded another clinical trial of FibroGen and AstraZeneca's roxadustat for anaemia caused by chronic kidney disease (CKD) before it will consider approval, setting up a length
AstraZeneca's Forxiga has become the first SGLT2 inhibitor to be approved in Europe for use in people with chronic kidney disease, extending its lead over rival drugs in the class.
The FDA has taken a longer than usual look at Ardelyx's regulatory submission for tenapanor, a drug for high blood phosphate levels associated with chronic kidney disease (CKD), and found i
Safety concerns seem to have scuppered any hope of a near-term approval for FibroGen and AstraZeneca's roxadustat for anaemia associated with chronic kidney disease (CKD) in the US, after F
Bayer's big investment in time and money on the development of finerenone for chronic kidney disease (CKD) in diabetics has paid off with an FDA approval, although it could face stiff compe
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