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BioWorld - Thursday, June 11, 2026
Home » Topics » Regulatory » EMA

EMA
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MAA validated for emtricitabine/rilpivirine/tenofovir combination tablet

Aug. 21, 2015

EMA to review MAA for palbociclib plus endocrine therapy for HR+/HER2- metastatic breast cancer

Aug. 21, 2015

Gamida Cell reaches agreements on phase III trial design for NiCord

Aug. 12, 2015

ProMetic Life Sciences completes first plasminogen dosing round in phase I trial

Aug. 11, 2015

Dicerna's DCR-PH1 receives orphan drug designation from the EMA

Aug. 7, 2015

EMA accepts filing of MAA for reslizumab

July 29, 2015

EMA committee hands down positive opinion for Zerbaxa

July 28, 2015

Obizur recommended for approval in Europe for acquired hemophilia A

July 28, 2015

EMA committee recommends approval of Cresemba for invasive aspergillosis and mucormycosis

July 28, 2015

EMA grants accelerated assessment to MAA for elotuzumab in MM

July 28, 2015
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