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BioWorld - Monday, June 29, 2026
Home » Topics » Regulatory » EMA

EMA
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EMA's CHMP grants positive opinion for dupixent for the treatment of atopic dermatitis

July 24, 2017

EMA committee recommends approval of label update for Lixiana

July 17, 2017

EMA validates pacritinib MAA for patients with myelofibrosis who have thrombocytopenia

July 14, 2017

Gilead Sciences' MAA for bictegravir/emtricitabine/tenofovir alafenamide FDC validated by EMA

July 14, 2017

ProQR Therapeutics receives orphan drug designations in E.U. and U.S. for QRX-411

July 7, 2017

RDD Pharma's RDD-0315 given orphan drug status in E.U.

July 7, 2017

Polatuzumab vedotin is eligible for access to EMA's PRIME program

June 30, 2017

Global Blood Therapeutics' GBT-440 obtains EMA PRIME designation

June 29, 2017

Stivarga for HCC approved in Japan, recommended for approval in E.U.

June 27, 2017

EC approves eslicarbazepine acetate monotherapy for newly diagnosed partial-onset epilepsy

June 26, 2017
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