The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmitted New Drug Application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adult patients with chronic kidney disease on dialysis who have had an insufficient response or intolerance to a phosphate binder therapy.
Intercept Pharmaceuticals has received orphan drug designation from US Food and Drug Administration (FDA) for the fixed-dose combination of obeticholic acid (OCA) and bezafibrate to treat individuals with primary biliary cholangitis (PBC).
Sweden-based Abliva has announced that its drug candidate NV354 has been received orphan drug designation (ODD) from the US FDA Office of Orphan Products Development to treat mitochondrial disease.
California-based AcelRx Pharmaceuticals has completed the divestment of DSUVIA to Alora Pharmaceuticals.
The US Food and Drug Administration (FDA) has granted fast track designation to Arrowhead Pharmaceuticals’ ARO-APOC3 that helps to lower triglycerides in adult patients with familial chylomicronemia syndrome (FCS).
Biotechnology firm Mediar Therapeutics has announced a $105m financing, which includes a recent $85m Series A round.
US Food and Drug Administration (FDA) has given approval to Nexus Pharmaceuticals for its Emerphed (ephedrine sulfate injection) in 25mg/5mL and 50mg/10mL single-dose pre-filled syringes.
The US Food and Drug Administration (FDA) has given approval to Takeda’s supplemental Biologics License Application (sBLA) for the expanded use of TAKHZYRO (lanadelumab-flyo) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in pediatric patients 2 to less than 12 years of age.
Spruce Biosciences and Kaken Pharmaceutical have signed an exclusive licensing agreement for the development and commercialisation of Spruce’s product candidate, tildacerfont, to treat congenial adrenal hyperplasia (CAH) in Japan.
Novartis has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Cosentyx (secukinumab) for usage either alone or in combination with methotrexate.
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