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tolvaptan

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Gilead gets OK for three-in-one hep C therapy in US

FDA clears the new product for the most common HCV genotypes

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Spark closes on first US gene therapy approval

FDA starts review of Luxturna for patients with inherited retinal disease

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FDA rejects Amgen’s osteoporosis hope romosozumab

Its partner UCB plans to submit the medicine for European approval later this year

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Amgen aspires to new Kyprolis label in the US and Europe

Appeals to regulators to add survival data to multiple myeloma drug's labelling

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FDA panel backs Avastin and Herceptin biosimilars

A decision from the US regulator is expected in September

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Novartis’ CAR-T clears FDA panel with relative ease

Puts tisagenlecleucel-T on course to be first approved personalised CAR-T therapy

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FDA halts third Merck myeloma trial after patient deaths

More patients died on Keytruda combination than those on other treatments

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Europe vs the US: New drug product approvals

As US approvals rates in the US drop,  the EU is not currently showing a similar trend

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EMA and FDA calls for innovative approaches for Gaucher disease medicines

The regulatory agencies also urge a similar method for all paediatric diseases

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FDA moves to tackle orphan designation backlog

Some 200 requests are awaiting review by the US regulator

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FDA panel backs CV claims for Novo Nordisk’s Victoza

LEADER trial shows the diabetes treatment reduces risk of cardiovascular death by 13%

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Bayer wins FDA approval for MS electronic autoinjector and app

US regulator gives green light to Betaconnect and myBETA app

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