Date of Publication: 27-Feb-2026 INTELLIGENCE OVERVIEWAgency: EMAApplicant: Sanofi Winthrop IndustrieProduct: Acoziborole WinthropThe European Medicines Agency (EMA) has highlighted a significant advancement with its update on a new single-dose oral treatment.…
Date of Publication: 19-Feb-2026 INTELLIGENCE OVERVIEWAgency: EMAThe European Medicines Agency (EMA) has published its updated pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2026. The document provides outcomes…
Date of Publication: 10-Feb-2026 INTELLIGENCE OVERVIEWAgency: EMAThe European Medicines Agency (EMA) has published the minutes of the Pharmacovigilance Risk Assessment Committee (PRAC) meeting held on 24–27 November 2025. The document…
Date of Publication: 09-Feb-2026 INTELLIGENCE OVERVIEWAgency: EMAThe European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has published its recommendations and safety signals adopted at the 12–15 January 2026 meeting, providing…
Date of Publication: 09-Feb-2026 INTELLIGENCE OVERVIEWAgency: AEMPS (Spain)/EMAThe European Medicines Agency (EMA) has published the January 2026 Bulletin of the Committee for Medicinal Products for Human Use (CHMP), outlining key…
Date of Publication: 30-01-2026 INTELLIGENCE OVERVIEW Agency: European Medicines Agency (EMA)Product: Neurocrine Netherlands B.V. - Efmody (Hydrocortisone)Indication: adrenal insufficiency (AI) Status: Positive CHMP opinion Industry Impact This decision highlights important regulatory and development…
Date of Publication: 30-01-2026 INTELLIGENCE OVERVIEW Agency: European Medicines Agency (EMA)Product: AstraZeneca AB. - Imfinzi (Durvalumab)Indication: Gastric or Gastro-oesophageal Junction Adenocarcinoma (GC/GEJC)Status: Positive CHMP opinion Industry Impact This decision reflects key regulatory and…
Date of Publication: 30-01-2026 INTELLIGENCE OVERVIEW Agency: European Medicines Agency (EMA)Product: Incyte Biosciences Distribution B.V. - Zynyz (Retifanlimab)Indication: Squamous Cell Carcinoma of the Anal Canal (SCAC)Status: Positive CHMP opinion Industry Impact This decision…
INTELLIGENCE OVERVIEW Agency: European Medicines Agency (EMA)Product: Sanofi – New medicinal productIndication: Chronic graft-versus-host disease (cGVHD)Procedure: CentralisedStatus: Positive CHMP opinion Date of Publication: 30-Jan-2026 The EMA’s Committee for Medicinal Products…
Agency/Company: European Medicines AgencyCountry: European UnionDate: 22-Jan-2026 Intelligence Overview: The European Medicines Agency’s guidance on the Product Management Service (PMS) highlights a major step forward in implementing ISO IDMP standards…