EC grants marketing authorisation to Givlaari® (givosiran) for acute hepatic porphyria
The developers of givosiran announced the European Commission (EC) has granted the drug marketing authorisation based on results of the Phase III ENVISION trial.
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The developers of givosiran announced the European Commission (EC) has granted the drug marketing authorisation based on results of the Phase III ENVISION trial.
The EMA has released an update on nitrosamines in drugs, saying that work is continuing to prevent and manage these impurities.
A report has suggested that number of Orphan Drug Designations in both the US and Europe is declining, possibly due to prices and political changes.
The EMA has recommended granting marketing authorisation to two medicines and extending the indications for three more following its latest meeting.
The FDA and EMA have accepted licence applications for ofatumumab, a novel B-cell therapy for patients with relapsing forms of multiple sclerosis (RMS).
After a review of cyproterone, the EMA has recommended that the drug only be prescribed once other treatment options have failed, due to an increased meningioma risk.
Bart Vansteenkiste explains why it is important to validate pharmaceutical labelling compliance to ensure good manufacturing practice.
The marketing license for ingenol mebutate gel (Picato) has been suspended by the MHRA due to studies showing an increased risk of skin malignancies from the drug.
Drug shortages can greatly impact patients and the pharmaceutical industry. Adrian van den Hoven, Director General of Medicines for Europe, explains how to prevent and reduce the effects of medicinal scarcities in the EU.
The EMA has released a statement on its efforts to support the development of a treatment for the novel coronavirus (2019-nCoV).
The EU Medical Devices Regulation will apply in May 2020. Maurits Lugard and Josefine Sommer of Sidley Austin LLP examine what the changes mean for the medtech industry.
A written statement from the UK government has highlighted the importance of trade co-operation with the EU, including for pharmaceuticals.
The EMA’s human medicines committee (CHMP) recommended fifteen medicines for various approvals at its January 2020 meeting; with ten drugs receiving marketing authorisation recommendations and five receiving positive opinions for specific treatments.
The EMA has released a statement, outlining the future for the UK's pharmaceutical industry in the transition period following Brexit and thereafter.
KTE-X19, an investigational CAR T-cell therapy, has been granted marketing authorisation by the European Commission.