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EMA releases results from February meeting, recommending two medicines EuropeanPharmaceuticalReview
March 03, 2020
The EMA has recommended granting marketing authorisation to two medicines and extending the indications for three more following its latest meeting.
Orphan drugs face uphill battle in 2020: GlobalData expresspharma
March 03, 2020
ODDs have been a focus of interest from the pharma industry for many years, with many companies enticed by the benefits of the enhanced regulatory processes, tax benefits and extended market exclusivity.
Numbers of Drug Approval by FDA, EMA and NMPA in 2019 En-CPhI.Cn
January 23, 2020
A quick review of drug approval in the past 2019 by NMPA, EMA and FDA.
ViiV Healthcare seeks EMA approval for HIV-1 drug candidate fostemsavir pharmaceutical-business-review
January 15, 2020
ViiV Healthcare has completed a regulatory filing in Europe seeking the approval for fostemsavir for the treatment of HIV-1 infection in adult patients having limited treatment options.
EMA announces launch of collaborative pilot scheme to inspect manufacturers europeanpharmaceuticalreview
January 03, 2020
The EMA will collaborate with other medicine regulatory bodies globally in a pilot programme to inspect sterile medicine manufacturers.
EMA releases findings from pharmacovigilance report europeanpharmaceuticalreview
December 19, 2019
A new pharmacovigilance document from the European Medicines Agency shows that the medicine safety system in the EU is effective.
EMA recommends five drugs for approval after December meeting europeanpharmaceuticalreview
December 17, 2019
The EMA’s CHMP has adopted a positive opinion for five medicines and recommended extending the indications for eight more.
Zotiraciclib granted Orphan Drug Designation by FDA and EMA europeanpharmaceuticalreview
December 09, 2019
The FDA and EMA have granted Orphan Drug Designation to zotiraciclib, currently the subject of two separate Phase Ib clinical trials in glioblastoma.
EMA CHMP recommends seven medicines for approval europeanpharmaceuticalreview
September 25, 2019
The EMA has suggested seven treatments to be granted marketing authorisations and also advocated indication extension for eight drugs.
Emmaus Life Sciences Announces Withdrawal of MAA to European Medicines Agency americanpharmaceuticalreview
September 23, 2019
Emmaus Life Sciences announced the withdrawal of its marketing authorization application (MAA) to the European Medicines Agency (EMA) for Xyndari™ (glutamine) for the treatment of sickle cell disease.

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