Date of Publication: 05-Feb-2026 INTELLIGENCE OVERVIEW Agency: US FDA The U.S. FDA has updated the safety labeling for Capecitabine to strengthen warnings related to Dihydropyrimidine Dehydrogenase (DPD) deficiency. The update…
INTELLIGENCE OVERVIEW The U.S. FDA has issued guidance on Computer Software Assurance (CSA) for Production and Quality Systems, introducing a risk-based, critical-thinking approach to software validation in the pharmaceutical and…
Date of Publication: 05-Feb-2026 INTELLIGENCE OVERVIEW The U.S. Food and Drug Administration (FDA) has announced its intent to take regulatory action against non-FDA-approved GLP-1 drug products, including certain compounded versions…
Date of Publication: 05-Feb-2026 (Official Gazette) INTELLIGENCE OVERVIEW Agency: Ministry of Health & Family Welfare – India/ The Gazette of India The Ministry of Health and Family Welfare (MoHFW), India,…
Date of Publication: 02-Feb-2026 INTELLIGENCE OVERVIEW Agency: Central Drugs Standard Control Organization - India/ Ministry of Health & Family Welfare - India The Ministry of Health and Family Welfare (MoHFW),…
Date of Publication (Latest update): 05-Feb-2026 INTELLIGENCE OVERVIEW The European Medicines Agency (EMA) has published an updated data protection notice for EudraVigilance (Human), clarifying how personal data are processed within…
Date of Publication: 05-Feb-2026 INTELLIGENCE OVERVIEW The EMA’s list of new human medicines under evaluation (February 2026) offers an early view into the next wave of therapies moving toward EU…
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…