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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
Pfizer and BioNTech announced Friday that they will hold off pursuing an expanded FDA Emergency Use Authorization (EUA) permitting use of their COVID-19 vaccine in children under age five, in order to gather more data on whether a third booster dose is needed. Read More
But Fleqsuvy is not approved for treating patients suffering from skeletal muscle spasms caused by rheumatic disorders, which are autoimmune, inflammatory conditions. Read More
The company wants to shift focus away from when exactly it will seek accelerated approval since the commercial impact is likely to be limited, said Daniel Skovronsky, Lilly’s chief scientific officer. Read More