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BioWorld - Wednesday, May 13, 2026
Home » Topics » Regulatory » EMA

EMA
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Bristol-Myers Squibb's Yervoy recommended for approval in Europe for pediatric melanoma

Dec. 19, 2017

EMA committee recommends approval of Alkindi for pediatric adrenal insufficiency

Dec. 18, 2017

EMA committee recommends approval of Ozempic for type 2 diabetes

Dec. 18, 2017

Celltrion's trastuzumab biosimilar recommended for E.U. approval

Dec. 18, 2017

EMA committee hands down positive opinion on burosumab for X-linked hypophosphatemia

Dec. 18, 2017

CHMP grants positive opinion to Cx601 for the treatment of perianal fistulas in Crohn's disease

Dec. 18, 2017

EMA's CHMP requests additional information for betrixaban MAA

Dec. 13, 2017

EMA validates application for Opdivo plus Yervoy in advanced renal cell carcinoma

Dec. 1, 2017

EMA gives orphan drug designation to ProQR Therapeutics' QR-313

Nov. 30, 2017

EMA grants orphan drug designation for DCC-2618 as treatment of gastrointestinal stromal tumors

Nov. 30, 2017
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