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BioWorld - Friday, April 24, 2026
Home » Topics » Regulatory » EMA

EMA
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EMA committee recommends approval of Prolia for bone loss associated with glucocorticoid therapy

April 30, 2018

Tagrisso receives positive opinion in Europe for first-line EGFR-mutated NSCLC

April 30, 2018

EMA's CHMP adopts positive opinion for Dzuveo

April 30, 2018

Biktarvy granted positive opinion in Europe

April 30, 2018

EMA validates type II variation for Keytruda with pemetrexed and chemotherapy in NSCLC

April 24, 2018

EMA grants orphan drug designation for ABO-202 gene therapy program in Batten disease

April 23, 2018

EMA committee hands down negative opinion for masitinib in ALS

April 20, 2018

KB-103 receives orphan medicinal product designation in Europe

April 20, 2018

FDA and EMA accept regulatory submissions for dacomitinib

April 5, 2018

EMA validates MAA for Lynparza in BRCA-mutated HER2-negative metastatic breast cancer

April 4, 2018
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