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Committee for Medicinal Products for Human USE

Showing 5 posts of 5 posts found.

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EMA lifts temporary ban on chikungunya vaccine Ixchiq following safety review

July 18, 2025
Medical Communications Committee for Medicinal Products for Human USE, European Medicines Agency (EMA), Ixchiq, Pharmacovigilance Risk Assessment Committee (PRAC), Vaccine, Virology, chikungunya

After completing a safety review of Ixchiq – a vaccine for chikungunya – the European Medicines Agency’s (EMA) safety committee …

News

Biocon Biologics gains EU approval for bone health therapies

July 4, 2025
Market Access, Medical Communications, Research and Development Biocon Biologics, Committee for Medicinal Products for Human USE, European Commission, Evfraxy, Oncology, Orthopaedics, Osteoporosis, Vevzuo, bone health, osteoporosis, prostate cancer

Biocon Biologics has announced that the European Commission has granted marketing authorisation for its denosumab biosimilars, Vevzuo and Evfraxy, marking …

News

Sarclisa recommended for EU approval in newly diagnosed multiple myeloma

June 24, 2025
Research and Development Committee for Medicinal Products for Human USE, EU, European Commission, European Medicines Agency, German-speaking Myeloma Multicenter Group, Oncology, Sanofi, blood cancer, monoclonal antibody

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended Sanofi’s Sarclisa (isatuximab) for approval in …

News
blood_test

CHMP issues positive opinion for Blenrep combinations in relapsed/refractory multiple myeloma

May 23, 2025
Market & Product Development, Medical Communications, Research and Development Blenrep, Committee for Medicinal Products for Human USE, European Medicines Agency, Oncology, multiple myeloma

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion …

News
Vaccination

EMA backs GSK’s malaria vaccine for use in Africa

July 24, 2015
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing CHMP, Committee for Medicinal Products for Human USE, EMA, European Medicines Agency, GSK, WHO, malaria, world health organization

GSK has taken a significant step forward toward being the first company to bring a malaria vaccine to market, after …

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Hansa Biopharma appoints Max Sakajja as Vice President, General Manager Europe and International

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GSK’s Exdensur receives MHRA approval for asthma and rhinosinusitis

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