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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
The FDA approved the 100th abbreviated new drug application (ANDAs) through its congressionally established Competitive Generic Therapy (CGT) pathway in 2021, bringing new low-priced medicines to the market for originator drugs that the agency had deemed to have inadequate generic competition. Read More