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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

EMA accepts Dupixent submission in asthma

April 3, 2018

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

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