EU EMA Medicines
Material regulatory developments from European Medicines Agency are tracked daily by Cresthaven Analytics. Over the last 90 days, 13 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
A selection of recent published briefs; this is not a complete archive.
EMA restricts approved indications for ipidacrine-containing medicines following CHMP benefit-risk review
The EMA's Committee for Medicinal Products for Human Use completed a benefit-risk review of ipidacrine-containing medicines on September 18, 2026. The Committee recommended narrowing approved indications and imposing pre…
Read the full EU EMA Medicines brief →EMA CHMP concludes sodium oxybate benefit-risk balance remains favourable but mandates new efficacy studies as marketing authorisation condition
The EMA's Committee for Medicinal Products for Human Use (CHMP) completed a referral review of sodium oxybate syrup and oral solution (175 mg/ml) used in alcohol dependence treatment. The benefit-risk balance remains fav…
Read the full EU EMA Medicines brief →EMA CHMP recommends 12 medicines for marketing authorisation following its September 2026 plenary meeting
The EMA's Committee for Medicinal Products for Human Use issued positive opinions on 12 medicines at its September 14–17, 2026 plenary meeting. Recommendations span oncology, haematology, neurology, dermatology, and infe…
Read the full EU EMA Medicines brief →EMA PRAC opens class-level safety review of injectable iron medicines over hypophosphataemia and bone-disease risk
The EMA Pharmacovigilance Risk Assessment Committee opened a formal safety review of injectable iron-containing medicines on September 4, 2026. The review targets hypophosphataemia and hypophosphataemic osteomalacia — in…
Read the full EU EMA Medicines brief →EMA finalises new manufacturing site registrations to resolve EU Visudyne shortage with full supply restoration targeted for 2027
The European Medicines Agency confirmed on September 4, 2026 that new supply arrangements for Visudyne (verteporfin) have been finalised, including registration of additional manufacturing sites. Full supply restoration …
Read the full EU EMA Medicines brief →EMA launches voluntary pilot for non-clinical NAM data submissions outside the marketing authorisation process
EMA has launched a voluntary pilot allowing companies, contract research organisations, and academic laboratories to share New Approach Methodologies data with regulators outside any marketing authorisation application. …
Read the full EU EMA Medicines brief →EMA grants conditional marketing authorisation for Vijoice, the first approved treatment for PIK3CA-related overgrowth spectrum disorders
The European Medicines Agency has recommended a conditional marketing authorisation for Vijoice (alpelisib) for adults and children aged 2 years and older with severe or life-threatening PIK3CA-related overgrowth spectru…
Read the full EU EMA Medicines brief →EMA recommends first oral GLP-1 receptor agonist for weight management, extending Wegovy's EU marketing authorisation
The European Medicines Agency has recommended extending the EU marketing authorisation for Wegovy (semaglutide) to include an oral tablet formulation for weight management in adults. This is the first oral GLP-1 receptor…
Read the full EU EMA Medicines brief →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…
Read the full EU EMA Medicines brief →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 …
Read the full EU EMA Medicines brief →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…
Read the full EU EMA Medicines brief →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 …
Read the full EU EMA Medicines brief →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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