After a complete response letter (CRL) from the U.S. FDA in 2022 and approvals in Europe, Japan and Australia, Akebia Therapeutics Inc.’s Vafseo (vadadustat) has finally been approved by the FDA. But the uphill climb still isn’t over for Akebia, as it has more hurdles to clear for the drug.
Metyos SAS has raised €2.3 million (US$2.7 million) in pre-seed funding for its biowearable sensor technology which monitors patients with chronic kidney disease (CKD). The funds will be used to progress the technology through clinical trials ahead of FDA approval.
Guard Therapeutics AB has presented progress within the company’s preclinical development platform, the GTX platform, aimed at developing new peptides based on the endogenous protein α-1-microglobulin.
Seoul-based Genexine Inc. filed a BLA to gain domestic approval of its follow-on biologic for chronic kidney disease (CKD)-induced anemia, Efesa (efepoetin alfa, GX-E4), to South Korean health regulators on Jan. 25.
Seoul-based Genexine Inc. filed a BLA to gain domestic approval of its follow-on biologic for chronic kidney disease (CKD)-induced anemia, Efesa (efepoetin alfa, GX-E4), to South Korean health regulators on Jan. 25.
Astrazeneca Korea Co. Ltd. will pull its blockbuster diabetes drug, Forxiga (dapagliflozin), from the South Korean market, a company official confirmed to BioWorld, citing “multiple factors” like increasing local competition and continuing price cuts after patent expiry in 2023.
Astrazeneca Korea Co. Ltd. will pull its blockbuster diabetes drug, Forxiga (dapagliflozin), from the South Korean market, a company official confirmed to BioWorld, citing “multiple factors” like increasing local competition and continuing price cuts after patent expiry in 2023.
Awak Technologies Pte Ltd. gained the U.S. FDA’s breakthrough designation for an artificial intelligence (AI)-based kidney disease progression prediction (KDDP) model on Nov. 27, following its $20 million fundraising that marked one of Singapore’s largest med-tech financings in 2023.
G1 and G2 genetic variants of the human APOL1 gene have been previously associated with an increased risk of developing chronic kidney diseases (CKD) in the African American population, and recent studies have shown that inhibition of APOL1 ion channel function could represent a novel therapeutic strategy for the treatment of patients with APOL1-like nephropathies.