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BioWorld - Thursday, June 18, 2026
Home » Topics » Regulatory » EMA

EMA
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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

EMA accepts Tagrisso submission in first-line EGFR-mutated NSCLC

Nov. 28, 2017

EMA accepts Macrilen MAA for adult growth hormone deficiency

Nov. 28, 2017

EMA launches improved version of EudraVigilance system for safety monitoring

Nov. 22, 2017

EMA announces relocation to the Netherlands

Nov. 21, 2017
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