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BioWorld - Wednesday, February 18, 2026
Home » Topics » Regulatory » EMA

EMA
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FDA and EMA offer Auris Medical guidance on phase II/III trial with Keyzilen

Sep. 16, 2019

EMA validates clinical development program for AB-8939

July 5, 2019

Brexit update: Industry again preparing for potential no-deal disruption to supply chains

July 2, 2019
By Nuala Moran
The industry is again preparing for a no-deal Brexit, as political shifts indicate that the U.K. crashing out of the EU on Oct. 31 is an increasingly likely outcome.
Read More

Kamada receives scientific advice from EMA for phase III trial of inhaled AAT

July 11, 2018

EMA validates Clovis' application for Rubraca as maintenance treatment for recurrent ovarian cancer

July 6, 2018

Detection of NDMA in Zhejiang Huahai's valsartan leads to EMA review and product recall

July 6, 2018

EMA committee recommends marketing authorization for Veyvondi

July 2, 2018

CHMP adopts positive opinion for Yescarta

July 2, 2018

Kymriah granted positive CHMP opinion for the treatment of two aggressive blood cancers

July 2, 2018

Vyxeos receives positive CHMP opinion

July 2, 2018
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