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Leqvio works by improving the liver’s ability to prevent the production of a protein that plays a role in keeping circulating cholesterol levels high. Read More
The FDA has approved Novartis’s new drug application (NDA) for its cholesterol-lowering drug Leqvio (inclisiran) after rejecting the NDA a year ago because of manufacturing concerns. Read More
High-quality evidence was lacking for most of the COVID-19 diagnostics, medical devices and drugs the FDA has granted Emergency Use Authorization (EUA) since the start of the pandemic, claimed researchers at Israel’s Tel-Aviv University in a provocative analysis in the journal JAMA Internal Medicine. Read More
The FDA has declined to approve Takeda Pharamceutical’s new drug application for TAK-721, developed to treat a chronic inflammatory disease of the esophagus known as eosinophilic esophagitis. Read More
In its first authorization of a COVID-19 antiviral for home use, the FDA yesterday granted Emergency Use Authorization (EUA) to Pfizer’s COVID-19 oral antiviral Paxlovid for adults at high risk of progressing to severe disease, when alternative therapies approved or authorized by FDA are not accessible or clinically appropriate. Read More
The FDA has approved Amgen’s blockbuster Otezla (apremilast) as a treatment for adults with plaque psoriasis of any severity, making it the first oral therapy cleared for that indication. Read More