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AbbVie Submits New Drug Application to U.S. FDA for Elagolix

AbbVie announced the submission of a New Drug Application to the U.S. Food and Drug Administration for elagolix, an investigational GnRH antagonist for the management of heavy menstrual bleeding associated with uterine fibroids in women.

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Myovant Sciences’ uterine fibroids combo therapy meets main goal in study

Myovant Sciences’ combination therapy met the main goal of a late-stage study testing the treatment in women with uterine fibroids.

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FDA Approves Novo Nordisk Hemophilia A Treatment

Denmark-based Novo Nordisk snagged approval from the U.S. FDA for a new treatment for hemophilia A, though Esperoct will not be available in the United States until 2020.

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Roche says Hemlibra effective in pivotal study

Roche’s Hemlibra provided sustained bleed control in the largest pivotal study to date of children with a form of hemophilia, the Swiss drugmaker said.

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U.S. FDA expands approval of Roche hemophilia drug

U.S. regulators approved expanded use of Roche’s drug Hemlibra to include almost all patients with hemophilia A.

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With Hemlibra, Roche seeks to break into tight hemophilia circle

Swiss drugmaker Roche is breaking into hemophilia A treatment, a $10 billion global market dominated by rivals who have cultivated close ties to sufferers of the genetic bleeding disorder.

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Bayer hemophilia treatment wins thumbs-up from EU panel

Bayer AG’s long-acting treatment for hemophilia A won a recommendation from a European Medicines Agency (EMA) panel for the treatment of the rare genetic disorder in which blood does not clot easily.

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FDA OKs Gazyva for new lymphoma indication

The U.S. regulatory agency approved Genentech’s Gazyva for patients with previously untreated advanced follicular lymphoma.

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Bayer, J&J in frame for bigger anti-clotting market opportunity

Bayer and Johnson & Johnson’s blockbuster clot prevention drug Xarelto was shown to cut the risk of potentially deadly strokes and heart attacks in patients with severe atherosclerosis by 24 percent, raising the prospects of billions more in sales.

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FDA grants priority review to hemophilia drug

Swiss pharma group Roche said the U.S. Food and Drug Administration granted priority review to its emicizumab for hemophilia A with inhibitors.

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