Following a milestone approval by the European Commission in July 2023, Vertex Pharmaceuticals has been granted a label expansion for its cystic fibrosis medicine KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) with ivacaftor.
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Following the CHMP’s recommendation of a follicular lymphoma combination treatment, if approved, BRUKINSA will be the first BTK inhibitor to be authorised for follicular lymphoma.
The European Commission has published its much-anticipated proposed revisions to the EU pharmaceutical legislation. While not as extensive as some had anticipated, with elements such as the supplementary protection certificate – the demise of which has been foretold for years – continuing albeit in a different form, Elisabethann Wright, Partner,…
Approval of BeiGene’s TEVIMBRA® (tislelizumab) in EU follows an agreement with Novartis to regain global rights of the antibody treatment.
The first long-acting injectable PrEP option proven superior to daily oral FTC/TDF in reducing HIV acquisition, has been approved in the European Union (EU).
New tax compliance cost and transfer pricing proposals from the European Commission (EC) aim to support simpler, clearer and more cost-effective tax systems in the EU.
To support small and medium-sized enterprises (SMEs) in the current economic climate, newly proposed measures aim to provide short-term relief, increase long-term competitiveness, and improve equality in the business environment across the Single Market.
Novartis will remove its sickle cell medicine crizanlizumab from the EU/EEA market following a European Commission decision.
GlobalData has shared research on how the loss of exclusivity of AbbVie’s Humira (adalimumab) is shaping the biosimilars market.