RAPS

EMA to offer recommendation on national use for Merck's molnupiravir

The European Medicines Agency (EMA) on Monday announced it is reviewing Merck Sharp & Dohme and Ridgeback Biotherapeutics' antiviral drug Lagevrio (molnupiravir) to treat COVID-19 in an effort to ...
Regulatory Affairs Professionals Society

Euro Roundup: EMA, HMA recommend regulatory changes to address radiopharmaceutical challenges

European authorities have recommended changes to the regulatory framework to keep pace with the progress of the ...
Yahoo

LEO Pharma applies to EMA to expand Anzupgo use to adolescents

Add Yahoo as a preferred source to see more of our stories on Google. In 2014 LEO Pharma has submitted an application to the European Medicines Agency (EMA) seeking to expand the label for Anzupgo ...
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EMA Accepts GSK's Filing for Expanded Use of RSV Vaccine Arexvy

GSK plc GSK announced that the European Medicines Agency (EMA) has accepted the regulatory application seeking approval to expand the use of its adjuvanted recombinant respiratory syncytial virus (RSV ...
Seeking Alpha

Acurx Announces Positive Opinion from EMA on Pediatric Investigation Plan for Ibezapolstat Use in Children with C. difficile Infection

STATEN ISLAND, N.Y., Sept. 30, 2025 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (ACXP) ("Acurx" or the "Company") is a late-stage biopharmaceutical company developing a new class of small molecule ...