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The FDA has issued a complete response letter (CRL) to Reata Pharmaceuticals, rejecting the company’s new drug application (NDA) for bardoxolone methyl for treatment of patients with Alport syndrome-related chronic kidney disease. Read More
Amryt Pharma received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for Oleogel-S10 for treating a rare genetic skin ailment — epidermolysis bullosa (EB). Read More
The antibody therapy received emergency authorization in December for treating immunocompromised people 12 years and older who may be unable to mount a proper immune response to a COVID-19 vaccine. Read More
The European Medicines Agency’s (EMA) human medicines committee gave a thumbs up to 13 new drugs, including two biosimilars and five generics, in its monthly meeting last week. Read More
Jardiance (empagliflozin), the type 2 diabetes and cardiovascular blockbuster developed by Eli Lilly and Boehringer Ingelheim, has expanded its indications with a new approval for reducing the risk of cardiovascular death and hospitalization in adults with heart failure and preserved left ventricular ejection fraction (LEVF). Read More
The FDA has issued a third Complete Response Letter (CRL) to Mallinckrodt for the company’s investigational drug terlipressin for the treatment of adults with hepatorenal syndrome (HRS), a life-threatening syndrome involving rapid reduction in kidney function. Read More
Endo Pharmaceuticals’ Symmetrel is also used to treat symptoms of Parkinson’s disease and Parkinson’s-like symptoms caused by certain medications. Read More
Pyrukynd is also being reviewed by the European Medicines Agency for treating adults with pyruvate kinase deficiency, and a regulatory decision is expected by the end of 2022. Read More