Pharmafile Logo

situximab

- 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

- PMLiVE

MSD probed by UK for blocking Remicade biosimilars

Pharma giant’s discount scheme for infliximab labelled ‘anti-competitive’

- PMLiVE

Keytruda is first FDA-approved drug for molecular indication

Indicates a significant development in the shift towards personalised medicine

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links