News

Sanofi receives orphan status from EMA for rilzabrutinib

Sanofi has received orphan designation from the European Medicines Agency (EMA) for rilzabrutinib, a reversible covalent ...
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ImmunityBio Wins U.K. Approval

Culver City-based ImmunityBio Inc. has started to take its Anktiva immunotherapy drug global. Last month, the United Kingdom ...
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Ascentage Pharma receives clearance from U.S. FDA, EMA to conduct GLORA-4

Ascentage Pharma (AAPG) announced that it has received clearance by the U.S. Food and Drug Administration, FDA, and the European Medicines Agency, ...

Moderna Receives European Commission Approval for Updated COVID-19 Vaccine Targeting SARS-CoV-2 Variant LP.8.1

CAMBRIDGE, MA / ACCESS Newswire / July 30, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the European Commission ...

WuXi Biologics Ireland Facility Receives EMA Approval for Commercial Manufacturing of Innovative Biologic

WuXi Biologics (Stock code: 2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today ...

Gilead Receives Positive CHMP Opinions Under Accelerated Review From European Medicines Agency for Twice-Yearly Lenacapavir for HIV Prevention

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion under accelerated ...

E.U. regulator approves injectable HIV drug that experts say could help stop transmission

Last year, studies suggested that lenacapavir, already used to treat people with HIV, was nearly 100% effective in stopping transmission in both women and men.
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European regulators to review GSK's asthma drug Nucala to treat COPD

The European Medicines Agency will review GSK's request to approve its asthma drug Nucala as an additional treatment for chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype ...