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Novartis’ Cosentyx beats J&J, Lilly to land first-in-class Chinese psoriasis nod
Novartis’ psoriasis blockbuster Cosentyx has beaten out rivals from Eli Lilly and Johnson & Johnson as the first interleukin-17A inhibitor approved in China.China’s National Medical Product Administration has approved Cosentyx to treat moderate-to-severe..
2019-04-08
Sage wins OK for depression drug Zulresso. Up next? Major marketing challenges
Sage Therapeutics now boasts the first-ever approval for a prescription drug for postpartum depression, thanks to the FDA’s Tuesday nod for Zulresso. But it also faces some big challenges in launching the new drug.Regulators greenlighted the product—a one-ti..
2019-03-21
Valsartan probe teaches FDA lesson about impurities in manufacturing
It was a U.S. drugmaker that first alerted the FDA that the valsartan API it got from a Chinese ingredient maker contained a potentially dangerous impurity. And in the process of investigating, the FDA learned something it hadn’t known: that a combination of ..
2018-09-10
The European Commission has approved Pfizer’s Xeljanz as a treatment for psoriatic arthritis (PsA), significantly expanding the drug’s scope.
European regulators are allowing use of Xeljanz (tofacitinib citrate) 5mg twice daily in combination with methotrexate for to treat active PsA in adults who have had an inadequate response or who have been intolerant to a prior disease-modifying anti-rheumatic..
2018-08-06
FDA approves Epclusa for treatment of chronic Hepatitis C virus infection
FDA approves Epclusa for treatment of chronic Hepatitis C virus infection~The U.S. Food and Drug Administration approved Epclusa to treat adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis (advanced liver disease). For patients..
2017-03-11
New US nod for Merck's nausea and vomiting drug
US regulators have approved a single-dose version of Merck & Co's chemotherapy-associated nausea and vomiting drug Emend.The jab's use has been cleared, in combination with other anti-emetics, for the prevention of delayed nausea and vomiting in ad..
2016-08-24
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