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EMA & EU

The European Medicines Agency, its committees (CHMP, PRAC), the European Commission, MDCG and EUDAMED.

32 stories

Regulatory News has published 32 EMA & EU stories between 15 July 2026 and 29 October 2026, each sourced to the primary record — the Federal Register entry, the Official Journal notice, the guidance document or the regulator’s own release — and written and edited by Connor Griggs, the publication’s editor. Last updated 29 October 2026.

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Showing 32 of 32 stories

A clinician reviews an anatomical illustration on a tablet with a patient, a generic stand-in for a clinic counseling visit For Physicians CHMP Backs Second Achondroplasia Drug, Dosed Weekly Oct 29, 20267 min read Read the story The Austrian Parliament building in Vienna behind the Athena fountain under a clear blue sky, a generic European-institutional stand-in Drugs & Biologics CHMP Rejects Omeros' Narsoplimab for Second Time Oct 25, 20266 min read Read the story A close-up of a curved EU institutional building facade against a blue sky, a generic stand-in for EU regulatory policy Guidance & Policy EMA, African Regulators Set Rules for Ebola Trials Oct 24, 20268 min read Read the story A pharmaceutical executive in an office setting, standing in for the CHMP's review of Eli Lilly's regulatory filing Drugs & Biologics CHMP Recommends Lilly's Oral GLP-1 Foundayo Oct 20, 20266 min read Read the story A researcher in a lab coat and face shield uses a pipette with blue reagent, standing in for small-molecule drug research For Physicians EMA Recommends First RAS Inhibitor for Pancreatic Cancer Oct 17, 20269 min read Read the story A businesswoman in a blazer reads a newspaper over coffee at her desk, a generic stand-in for a company reviewing its own regulatory news Spotlight Ascendis Wins CHMP Backing for Achondroplasia Drug Yuviwel Oct 17, 20266 min read Read the story European Union flags flying in front of the European Parliament building in Strasbourg under a clear sky Drugs & Biologics EMA Recommends EU Approval for RAS-Inhibitor Rasonque Oct 17, 20266 min read Read the story Four colleagues shake hands and smile in a bright office setting Clinical Trials EMA Makes Pre-CTA Trial Advice Pilot Permanent Oct 10, 20265 min read Read the story A professional reviews documents and a laptop at a bright office desk by a window Guidance & Policy EU Council Adopts Pharma Package, Sends to Parliament Oct 5, 20266 min read Read the story A researcher in a hairnet and lab coat adjusts a microscope at a bright laboratory bench Drugs & Biologics Pierre Fabre Refiles Ebvallo BLA After FDA Reversal Oct 4, 20265 min read Read the story A white institutional office building photographed from below against a clear blue sky Guidance & Policy EMA, MHRA Lead Call for Animal-Testing Alternatives Oct 2, 20265 min read Read the story A professional reviewing paperwork at a desk in a bright office with plants Spotlight AnaCardio Raises €62.5M to Fund Heart Drug Phase 2b Oct 1, 20266 min read Read the story A team stacks hands together in celebration in an office, with a market chart visible on a screen behind them Spotlight IMPACT Therapeutics Clears CHMP for Ovarian Cancer Drug Sep 30, 20267 min read Read the story A clinician in a white coat examines a patient at an ophthalmic slit lamp Guidance & Policy EU's IVDR Class C Notified-Body Deadline Passes Sep 30, 20267 min read Read the story A man in a light blue dress shirt sits at a desk beside floor-to-ceiling windows, smiling Spotlight LEO Pharma Wins CHMP Nod to Treat Teen Eczema Sep 28, 20267 min read Read the story A smiling executive stands with arms crossed in front of a window overlooking trees Spotlight Incyte Lands EU Backing for First Oral HS Pill Sep 27, 20267 min read Read the story A physician in a white coat with a stethoscope writes notes on a folder against a plain studio background Drugs & Biologics EU Approves First Drug for Cerebral ALD Sep 26, 20265 min read Read the story A team of five colleagues put their hands together in the middle of a bright, window-lit room, celebrating together Spotlight Betta's Gevalka Clears CHMP for Lung Cancer Sep 25, 20266 min read Read the story A woman leads a discussion at the head of a conference table while colleagues around her react and take notes Spotlight CHMP Recommends Zealand's Zeydovio for Bowel Disease Sep 24, 20266 min read Read the story A researcher in a lab coat examines petri dish cultures under a microscope Drugs & Biologics CHMP Clears First mAb Biosimilar Under New EU Path Sep 22, 20266 min read Read the story A researcher in safety glasses and blue gloves inspects a laboratory sample Drugs & Biologics CHMP Backs Corcept's Lifyorli for Ovarian Cancer Sep 21, 20266 min read Read the story Two officials in dark suits sign documents at a conference table with a European Union flag between them Drugs & Biologics CHMP Backs AstraZeneca's Klygefa for Rare Disorder Sep 20, 20265 min read Read the story Two officials sign documents at a table bearing European Union and American flags while colleagues review papers standing behind them Drugs & Biologics CHMP Recommends Novo's Frehemgo for Haemophilia A Sep 19, 20265 min read Read the story A paramedic in blue gloves holds an LVOne test cassette in front of a yellow NHS ambulance Spotlight UpFront Diagnostics Earns CE Mark for Stroke Test Sep 17, 20265 min read Read the story A close-up of a hand signing an official multi-page form on a desk, with reading glasses resting nearby Guidance & Policy EMA Extends PV Inspections to Cover Subcontractors Sep 12, 20264 min read Read the story A close-up of a hand signing an official document with a pen Drugs & Biologics EMA Reviews Injectable Iron Drugs Over Bone-Risk Reports Sep 11, 20264 min read Read the story Three scientists in a sunlit lab examine a bottle and a bowl of solution while adjusting laboratory equipment Drugs & Biologics EU Approves GSK's Twice-Yearly Asthma Drug Exdensur Aug 25, 20265 min read Read the story A researcher in white scrubs examines a conical flask of blue solution while a colleague takes notes across the bench Drugs & Biologics EU Clears Tecvayli Plus Daratumumab for Myeloma Aug 24, 20265 min read Read the story A gloved hand adjusts the focus stage of a laboratory microscope holding a slide Drugs & Biologics CHMP Rejects Arimoclomol Again; Zevra Seeks Re-Examination Jul 27, 20266 min read Read the story A gloved hand reaches for a rack of blood sample tubes with pink caps on a laboratory bench Drugs & Biologics CHMP Backs the EU's First Refillable Eye Implant Jul 26, 20266 min read Read the story A woman in glasses smiles while speaking at a lectern beside a European Union flag, addressing seated attendees Guidance & Policy Brussels Says Only Manufacturers May Assign a Device's UDI Jul 24, 20265 min read Read the story The hemicycle of the European Parliament in Brussels Guidance & Policy EUDAMED's Next Deadline Is Narrower Than It Looks Jul 15, 20266 min read Read the story