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Depression drug Spravato wins European panel vote

Johnson & Johnson’s Spravato, a nasal spray for depression and potential blockbuster medicine, won recommendation for approval from a European Medicines Agency panel.

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Pfizer’s Avastin biosimilar wins FDA approval

The U.S. Food and Drug Administration approved Pfizer Inc.’s biosimilar to Roche Holding AG’s blockbuster cancer treatment Avastin.

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GSK’s HIV drug wins European panel thumbs-up

GlaxoSmithKline’s two-drug treatment for HIV infections won marketing approval from a European Medicines Agency panel. The British drugmaker received U.S. FDA approval in April 2019.

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EU panel approves drug for rare genetic disease

An advisory committee of the EMA recommended conditionally approving a drug from Akcea Therapeutics and Ionis Pharmaceuticals that aims to treat a rare genetic disease.

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Shire’s Takhzyro for rare swelling disorder wins European panel green light

An EMA panel recommended approving a potential blockbuster drug from Shire Plc to treat a rare hereditary disease.

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Sanofi receives positive CHMP opinion for dengue vaccine

The European Medicines Agency’s CHMP adopted a positive opinion for the marketing authorization of Sanofi’s dengue vaccine.

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EMA committee recommends restrictions on fluoroquinolone, quinolone antibiotics

The EMA’s risk assessment committee recommended restrictions on the use of the broad-spectrum antibiotics.

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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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Lilly migraine drug wins European panel thumbs-up

A European Medicines Agency panel recommended the approval of U.S. pharmaceutical group Eli Lilly’s migraine treatment, bringing the drug one step closer to being sold in the European Union.

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Takeda lung cancer drug gets European panel nod

Takeda Pharmaceutical Co.’s lung cancer drug Alunbrig received the recommendation of a European Union panel, more than a year after winning U.S. regulatory approval.

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