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CAMBRIDGE, MA / ACCESS Newswire / July 30, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the European Commission ...
BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the European Medicines Agency (EMA) has ...
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Pharmaceutical Technology on MSNBeOne Medicines’ BTK degrader gains EMA PRIME designationThe designation was based on the therapy’s novel mechanism and data showing its anti-tumour activity in B-cell malignancies.
The European Medicines Agency has recommended authorizing a twice-yearly injectable drug to prevent HIV. Scientists say this ...
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DPA International on MSNEMA recommends approval of additional Alzheimer's treatmentThe European Medicines Agency (EMA) cleared the way for the use of another drug to treat Alzheimer's disease on Friday.
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Pharmaceutical Technology on MSNGilead wins positive European approval opinion for twice-yearly HIV injectionThe European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Gilead ...
Certara, Inc., a global leader in biosimulation, today announced that the European Medicines Agency (EMA) has formally qualified the Simcyp® Simulator for use in regulatory submissions across the EU.
European regulators said that Eli Lilly’s Alzheimer’s treatment Kisunla should be approved for select patients.
The European Medicines Agency (EMA) has finally joined the discussion on artificial intelligence (AI) and machine learning (ML), releasing a draft reflection paper on the use of these technologies ...
The European Medicines Agency has granted orphan drug designation to narsoplimab for treatment in hematopoietic stem-cell transplant. About Hematopoietic stem cell transplant-associated thrombotic ...
On 21 October 2019, the European Medicines Agency (EMA) published a guide for assessors of centralised applications for marketing authorisation. The guide focuses on the wording used in ...
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