The European Commission has granted marketing authorisation to Stelara (ustekinumab) to treat patients aged six to 11 with moderate to severe plaque psoriasis.
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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.
Ten priority actions have been recommended for the European medicines regulatory network to evolve its approach to data use.
Janssen have applied to the EMA to extend the use of esketamine to a short-term treatment for the rapid reduction of depressive symptoms in adults with MDD who are suicidal with the intent.
The Japanese Ministry of Health, Labour and Welfare (MHLW) has granted marketing approval for Dovato, a treatment for HIV-1 infection.
The EMA will collaborate with other medicine regulatory bodies globally in a pilot programme to inspect sterile medicine manufacturers.
Lumasiran, an investigational drug to treat primary hyperoxaluria type 1, has met its endpoints in clinical trials.
This article highlights the 10 most popular news stories published by European Pharmaceutical Review in 2019.
A new pharmacovigilance document from the European Medicines Agency shows that the medicine safety system in the EU is effective.
ViiV Healthcare has filed submissions to the FDA and EMA for the first dispersible formulation of dolutegravir (DTG) for children living with HIV.
The EMA’s CHMP has adopted a positive opinion for five medicines and recommended extending the indications for eight more.
The EMA has announced that metformin tablets from outside the EU do not contain unacceptable levels of NDMA impurities and EU metformin is not affected.
The FDA and EMA have granted Orphan Drug Designation to zotiraciclib, currently the subject of two separate Phase Ib clinical trials in glioblastoma.
In the wake of Brexit, the pharma industry will need to respond to a new regulatory landscape. Peter Morgan discusses how businesses have to prepare for the oncoming political changes, all whist retaining high pharmaceutical product quality.