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- PMLiVE

icosapent ethyl

- PMLiVE

Spark closes on first US gene therapy approval

FDA starts review of Luxturna for patients with inherited retinal disease

- PMLiVE

FDA rejects Amgen’s osteoporosis hope romosozumab

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

- PMLiVE

Amgen aspires to new Kyprolis label in the US and Europe

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

- PMLiVE

FDA panel backs Avastin and Herceptin biosimilars

A decision from the US regulator is expected in September

- PMLiVE

Novartis’ CAR-T clears FDA panel with relative ease

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

- PMLiVE

FDA halts third Merck myeloma trial after patient deaths

More patients died on Keytruda combination than those on other treatments

- PMLiVE

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

- PMLiVE

EMA and FDA calls for innovative approaches for Gaucher disease medicines

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

- PMLiVE

FDA moves to tackle orphan designation backlog

Some 200 requests are awaiting review by the US regulator

- PMLiVE

FDA panel backs CV claims for Novo Nordisk’s Victoza

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

Bayer symbol

Bayer wins FDA approval for MS electronic autoinjector and app

US regulator gives green light to Betaconnect and myBETA app

Eli Lilly HQ

FDA fast-tracks Pfizer and Lilly’s tanezumab

The novel pain drug treats osteoarthritis and chronic low back pain

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