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BioWorld - Tuesday, May 5, 2026
Home » Topics » Regulatory » EMA

EMA
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CHMP issues positive opinion on Avastin biosimilar ABP-215

Nov. 13, 2017

EMA committee recommends expanding approval of Orkambi

Nov. 13, 2017

EMA's CHMP supports expanding Nplate indication

Nov. 13, 2017

FDA gives orphan status to Achillion's ACH-4471 for PNH

Nov. 8, 2017

Pegfilgrastim biosimilar from Sandoz accepted for EMA review

Oct. 31, 2017

VBL Therapeutics' VB-111 granted orphan medicinal product status in E.U.

Oct. 23, 2017

EMA grants orphan drug designation to G-100 for the treatment of follicular non-Hodgkin's lymphoma

Oct. 20, 2017

EMA grants orphan drug designation to Conatus' IDN-7314 for primary sclerosing cholangitis

Oct. 19, 2017

Ignyta's entrectinib obtains PRIME designation from EMA

Oct. 18, 2017

EMA's CHMP supports expansion of marketing authorization for Zytiga

Oct. 16, 2017
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