Obtaining the Marketing Authorisation Application (MAA) is a key step in the commercialization of drugs in the EU, and also an important help to promote the global market expansion of pharmaceutical ...

The EMA PDCO approved the clinical program to evaluate ... a prerequisite for filing a Marketing Authorization Application (MAA). About acute Graft-versus-Host Disease Acute Graft-versus-Host ...

MaaT Pharma (EURONEXT: MAAT ? the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for ...

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Europe’s drug regulatory agency has given Kizfizo a negative opinion for the second time, following one from November 2024.

Copenhagen, Denmark Monday, March 10, 2025, 11:00 Hrs [IST] ...

Zevra Therapeutics, Inc. ( NASDAQ: ZVRA) Q4 2024 Earnings Conference Call March 11, 2025 4:30 PM ET Nichol Ochsner - VP, IR and Corporate Communications Neil McFarlane - President and CEO LaDuane ...

Joenja® (leniolisib) marketed in the U.S. - the first and only approved disease modifying ... activities requested by the European Medicines Agency's (EMA) Committee for Human Medicinal Products ...

today announced the European Medicines Agency (EMA) has accepted for review and begun assessing the marketing authorization application (MAA) for ANKTIVA (nogapendekin alfa inbakicept-pmln ...