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Bayer in frame to win first EU nod for high-precision cancer drug

The EMA recommended approving Vitrakvi to tackle tumors with a specific genetic mutation regardless of where the disease started.

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European panel clears GW Pharma cannabis drug

GW Pharmaceuticals’ marijuana-based treatment Epidyolex won a positive recommendation for marketing approval from a European Medicines Agency (EMA) panel for use as an additional treatment for two types of seizures.

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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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Teva’s migraine drug gets EU panel nod

Teva Pharmaceutical Industries said a European Medicines Agency panel recommended approving the migraine treatment Ajovy, a drug being counted on to revive the company’s fortune.

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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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Novartis, aiming to go toe-to-toe with Humira, wins EU panel nod

Novartis’ generics unit won a European panel’s recommendation for its biosimilar version of AbbVie’s Humira as the Swiss drugmaker aims to take a bite out of sales of the world’s best-selling medicine.

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Novartis wins key European panel’s thumbs-up for migraine drug

Novartis’ new migraine drug Aimovig won a key recommendation from a key European panel on Friday, helping open the way for potential sales before the end of the year for a medicine the Swiss drugmaker is counting on to boost growth.

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