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…
Date of Publication: 01-Feb-2026 INTELLIGENCE OVERVIEW Agency: US FDA The U.S. Food and Drug Administration (FDA) has launched the PreCheck Pilot Program, an initiative designed to modernize regulatory oversight of sterile pharmaceutical…
Date of Publication: 29-Jan-2026 INTELLIGENCE OVERVIEW Agency: US FDA Regulatory authorities have issued updated guidance on Clinical Decision Support (CDS) software, clarifying how such tools are regulated when used to support healthcare…
Date of Publication: 02-02-2026 INTELLIGENCE OVERVIEW Agency: European Medicines Agency (EMA) The European Medicines Agency (EMA) has published a reflection paper on the qualification of non-mutagenic impurities, providing scientific guidance on…
Date of Publication: 30-01-2026 INTELLIGENCE OVERVIEW Agency: European Medicines Agency (EMA) The European Medicines Agency (EMA) has released a draft reflection paper outlining scientific principles for the qualification and control of…
INTELLIGENCE OVERVIEW The European Medicines Agency (EMA) has issued a Validation Checklist for Type II (non)clinical variations, defining the mandatory documentation required for successful validation of post-authorisation variation applications. Date…
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…