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BioWorld - Wednesday, April 15, 2026
Home » Topics » Regulatory » EMA

EMA
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EMA accepts cemiplimab MAA for cutaneous squamous cell carcinoma

April 3, 2018

Lanadelumab submissions in E.U. and Canada accepted for review

March 29, 2018

EMA accepts BioMarin's MAA for pegvaliase to treat adults with PKU

March 29, 2018

EMA validates application for Cabometyx for previously treated advanced HCC

March 28, 2018

EMA committee recommends approval of new dosing schedules for Opdivo in E.U.

March 27, 2018

EMA grants PRIME designation for lumasiran in primary hyperoxaluria type 1

March 27, 2018

CHMP supports conditional marketing authorization for Clovis Oncology's Rubraca

March 26, 2018

Amgen, Allergan receive positive opinion in E.U. for ABP-980

March 26, 2018

EMA recommends including new indication in Repatha label

March 26, 2018

EMA committee issues negative opinion on Portola's betrixaban

March 26, 2018
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