EC grants Orphan Drug Designation to FLT190, a Fabry Disease treatment
FLT190 gene therapy has been granted Orphan Drug Designation based on preliminary trial data and the positive opinion of an EMA committee.
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FLT190 gene therapy has been granted Orphan Drug Designation based on preliminary trial data and the positive opinion of an EMA committee.
The developers of givosiran announced the European Commission (EC) has granted the drug marketing authorisation based on results of the Phase III ENVISION trial.
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.
KTE-X19, an investigational CAR T-cell therapy, has been granted marketing authorisation by the European Commission.
The EC, EMA and HMA have published key principles on the various benefits of sharing medicinal product information electronically and how to implement this system.
Mayzent (siponimod) has been approved by the European Commission (EC) for adults with secondary progressive multiple sclerosis (SPMS) based on the results of the EXPAND trial.
The European Commission has granted marketing authorisation to Stelara (ustekinumab) to treat patients aged six to 11 with moderate to severe plaque psoriasis.
A novel formulation for dolutegravir has been developed to improve HIV treatment options for children. Dr Kimberly Smith from ViiV Healthcare discusses the benefits of this new dispersible tablet.
EU marketing authorisation has been given to Sunosi (solriamfetol) for excessive daytime sleepiness in adults with narcolepsy or obstructive sleep apnea.
The European Commission (EC) granted marketing authorisation for Darzalex in combination with bortezomib, thalidomide and dexamethasone (VTd) for multiple myeloma patients.
Marketing authorisation has been granted by the EC for Evenity® (romosozumab) to treat osteoporosis in postmenopausal women.
The European Commission has approved the label extension for KALYDECO® (ivacaftor) to include the treatment of infants with cystic fibrosis between six and 12 months old.