Pharmaceutical Technology on MSN21d
Biogen’s higher dose Spinraza under review by US and EU regulators
Biogen’s applications for the higher dose regimen of SMA drug Spinraza are now under review in the US and Europe.
Bio-Thera Solutions Announces Regulatory Filing Acceptance For BAT2506, A Proposed Biosimilar To Simponi®, In The European Union
The European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for BAT2506 as a biosimilar to reference p ...
TASS6y
BIOCAD’s CEO Dmitry Morozov: Chinese market is our company’s priority
What about competition in this segment both on ... We have already held consultations with the ЕМА (The European Medicines Agency) and agreed on the protocol design. Similar trials will be ...
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Acadia Pharmaceuticals Submits Marketing Authorization Application to the European Medicines Agency for Trofinetide for the Treatment of Rett Syndrome
SAN DIEGO--(BUSINESS WIRE)--Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the company has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency ...