The US Food and Drug Administration (FDA) has narrowly beaten the European Medicines Agency (EMA) to the most approved drugs with a new active substance in 2024. On 15 January, the two agencies ...

AUSTRALIAN energy firm, Invictus Energy Limited, has secured an environmental social impact assessment approval from the Zimbabwe Environmental Management Agency (Ema) to begin gas production at ...

Now, the CHMP has backed conditional approval of Zolgensma for babies and young children with SMA, which could lead to full EMA approval within the next couple of months. Novartis says it will ...

The EMA previously granted orphan designation to mavorixafor in WHIM syndrome. In April 2024, mavorixafor received U.S. Food and Drug Administration approval as XOLREMDI , an oral, once-daily ...

The Montreal-based C3i Center obtained regulatory approval from the European Medicine Agency (EMA) to produce cell therapy therapies for the European market. The company obtained a certificate of ...

announces that it has obtained regulatory approval from the EMA (European Medicine Agency) to produce cell therapy treatments for the European market. C3i, therefore, obtains a certificate of GMP ...

Approval from EMA to expand the Phase III trial FLAMINGO-01 into Europe enhances the company's research capabilities and potential market reach. The activation of approximately 110-115 clinical ...

MONTRÉAL, Feb. 19, 2025 (GLOBE NEWSWIRE) -- C3i Center (C3i) announces that it has obtained regulatory approval from the EMA (European Medicine Agency) to produce cell therapy treatments for the ...