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- PMLiVE

Sputnik V

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EMA gives December deadline for information updates

Pharma companies must revise their medicines information by year-end

- PMLiVE

EMA: We will allow clinical data download

Regulator says it hasn't watered down trial transparency measures

- PMLiVE

EMA adaptive licensing project gathers pace

Regulator picks two drugs to pilot early access scheme

Roche - Basel

CHMP turns down Avastin for brain cancer

Roche set to be denied expanded use for oncology drug in Europe

- PMLiVE

CHMP backs European approval for six new medicines

Recommends drugs by PTC Therapeutics, Roche, Biogen Idec, Octapharma, Alcon and Veloxis Pharma

- PMLiVE

Teva backs laquinimod for MS despite CHMP rejection

EMA confirms negative opinion after re-examination

- PMLiVE

Following the biologic path

Biosimilar regulations in Canada, the US and Europe all have a degree of uncertainty

- PMLiVE

Bayer’s Nexavar recommended for thyroid cancer in EU

CHMP backs extra indication for cancer drug

- PMLiVE

GSK’s Mekinist on course for EU melanoma approval

Only new medicine recommended in latest CHMP opinions

- PMLiVE

EMA warns on stolen Herceptin

Says vials of cancer drug have been tampered with and re-introduced into supply chain

- PMLiVE

EMA to carry out four safety reviews

And recommends against combination of medicines affecting RAS system in latest PRAC highlights

- PMLiVE

EU and Australian regulators collaborate on rare diseases

EMA and Therapeutic Goods Administration to share reports for orphan drugs

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