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- PMLiVE

Mysimba

- PMLiVE

CHMP backs three immuno-oncology drugs for solid tumours

Roche, MSD and Merck/Pfizer are all on course for new European approvals later this year

- PMLiVE

Sanofi and Regeneron win CHMP nod for Dupixent

Atopic dermatitis treatment backed for European approval

- 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

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

UK signals desire for close post-Brexit relationship with EU

Health and business ministers outline areas where collaboration may continue

- 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

Europe delays EMA relocation decision

Will resolve the issue in November, one month later than expected

- PMLiVE

Shoring up the framework

European regulators add a measure of clarity to pharma’s uncertainty around Brexit

- PMLiVE

Samsung Bioepis wins CHMP nod for second Humira biosimilar

In addition to Imraldi the regulatory advisors also backed new medicines from AbbVie and Gilead

- PMLiVE

Merck gets CHMP backing for long-delayed oral MS drug

Cladribine, which will be branded as Mavenclad, was originally rejected by the committee in 2010

- PMLiVE

European regulators mull use of… QR codes

EMA’s Heads of Medicines Agencies committee outlines packaging proposals

Novartis building

Novartis’ Zykadia claims US approval for first-line lung cancer

The Swiss pharma giant’s drug also receives CHMP positive opinion

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