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Astellas Pharma and Fibrogen have received EU approval for Evrenzo (roxadustat) for treating adults with anemia associated with chronic kidney disease (CKD) — mere days after the FDA rejected the drug for the same indication in the U.S. Read More
The FDA is giving Covis Pharmaceuticals’ Makena — a hydroxyprogesterone caproate injection to reduce the risk of preterm birth in high-risk women — another chance to prove itself. Read More
Eli Lilly and partner Boehringer-Ingelheim scored a win in the cardiology arena this week, with the FDA’s approval of Jardiance (empagliflozin) for patients who have heart failure with reduced ejection fraction. Read More
The FDA has granted GlaxoSmithKline’s (GSK) monoclonal antibody Jemperli (dostarlimab) an expanded indication for treating adults with mismatch repair-deficient (dMMR) recurrent or advanced solid tumors, usually found in endometrial, colorectal or other gastrointestinal cancers. Read More
Lyumjev first received FDA approval in June 2020 to reduce blood sugar levels and accelerate insulin uptake following meals in adults with type 1 and 2 diabetes. Read More
The approval was based on data “showing an overall response rate across three different types of VHL-associated tumors,” noted the open-label study’s principal investigator. Read More
Ipsen has withdrawn its new drug application (NDA) for palovarotene, an experimental treatment for an ultra-rare genetic disorder that causes tendons and ligaments to be replaced by bone. Read More
The FDA has rejected Sesen Bio’s biologics license application (BLA) for Vicineum (oportuzumab monatox-qqrs) for treating a form of bladder cancer. Read More