EU EMA Medicines
Material regulatory developments from European Medicines Agency are tracked daily by Cresthaven Analytics. Over the last 90 days, 12 material briefs relevant to professionals operating in the healthcare & life sciences sector have been published below. Each brief is sourced directly from the primary regulatory feed, summarized for institutional readers, and scored for materiality.
Recent material activity
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EMA grants EU marketing authorisation for Susvimo ocular implant delivering ranibizumab for stable neovascular AMD
The EMA has recommended EU marketing authorisation for Susvimo (ranibizumab), delivered via a refillable ocular implant, for adults with stable neovascular age-related macular degeneration. The authorisation applies only…
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EMA recommends EU marketing authorisation for Icotyde, the first oral interleukin-23 receptor antagonist for plaque psoriasis
The EMA has recommended marketing authorisation in the European Union for Icotyde (icotrokinra) for moderate-to-severe plaque psoriasis in adults and adolescents aged 12 and older weighing at least 40 kg. Icotyde is the …
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EMA PRAC adopts new safety information for desogestrel and etonogestrel contraceptives and Litfulo following July 2026 review
The European Medicines Agency's Pharmacovigilance Risk Assessment Committee concluded its July 6–9, 2026 meeting with agreed safety updates for desogestrel- and etonogestrel-containing contraceptives and Litfulo, a treat…
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EMA initiates rolling review for an investigational medicine targeting metastatic pancreatic cancer under accelerated assessment procedures
The European Medicines Agency has initiated a rolling review for an investigational medicine targeting metastatic pancreatic cancer, which the agency classifies as a high unmet medical need condition. The rolling review …
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EMA CHMP recommends EU marketing authorisation revocation for Tavneos following GCP breach finding in pivotal trial
The EMA's Committee for Medicinal Products for Human Use recommended on June 27, 2026 that the EU marketing authorisation for Tavneos (avacopan) be revoked. The recommendation follows a data integrity review concluding t…
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EMA CHMP June 2026 meeting yields six new positive opinions, three negative opinions, and a revocation recommendation for Tavneos
The EMA's Committee for Medicinal Products for Human Use concluded its June 22–25, 2026 meeting with positive opinions on six new medicines, twelve indication extensions, and one re-examination reversal. The committee al…
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EMA PRAC concludes inconsistent evidence on paternal valproate neurodevelopmental risk and recommends product information updates
The EMA Pharmacovigilance Risk Assessment Committee published meeting highlights on 12 June 2026 covering its 8-11 June session, reference EMA/PRAC/115322/2026. The Committee found that evidence of neurodevelopmental ris…
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EMA Emergency Task Force recommends COVID-19 vaccine composition update to XFG variant for 2026/2027 campaign
EMA's Emergency Task Force (ETF) published a recommendation on May 29, 2026 to update COVID-19 vaccine compositions to target the SARS-CoV-2 XFG variant for the 2026/2027 vaccination campaign. The recommendation initiate…
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EU EMA Medicines release pending Cresthaven Analytics full analysis: New medicine for two types of pulmonary fibrosis
EU EMA Medicines published a regulatory release titled 'New medicine for two types of pulmonary fibrosis'. Cresthaven Analytics' full intelligence brief is pending re-analysis; see the source link below for the complete …
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EU EMA Medicines release pending Cresthaven Analytics full analysis: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 May 2026
EU EMA Medicines published a regulatory release titled 'Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 May 2026'. Cresthaven Analytics' full intelligence brief is pending re-analy…
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EU co-legislators reach provisional agreement on the Critical Medicines Act covering supply chain resilience obligations
The European Medicines Agency published a statement on May 12, 2026 welcoming the provisional political agreement reached between the European Parliament and the Council of the European Union on the proposed Critical Med…
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EMA issues 2026/2027 seasonal influenza vaccine strain composition recommendations for EU manufacturers
The European Medicines Agency published updated strain composition recommendations on 7 May 2026 for seasonal influenza vaccines covering the 2026/2027 Northern Hemisphere season. The recommendations specify required vir…
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