Regulatory intelligence articles
Article-scoped records from major regulators, with primary-source evidence separated from AI-assisted context.
FDA Approves First Treatment for MCT8 DeficiencyFDA Intends to Evaluate Changes to the PMTA Regulatory FrameworkFederal Court Enters Consent Decree Against Gold Star Distribution, Inc.MHRA approves lurbinectedin for adults with extensive‑stage small cell lung cancerCHMP meeting highlights 14–17 September 2026FDA approves first gene therapy for pediatric Sanfilippo syndrome Type AFDA Launches Expedited IND Pilot, Begins Accepting ApplicationsIndependent Commission publishes blueprint to accelerate safe AI adoption in UK healthcareFDA Grants Accelerated Approval to a New Breast Cancer TreatmentFDA Approves First Drug to Treat Alexander DiseaseEMA launches voluntary data submission pilot to advance innovative alternatives to animal testingMHRA concludes review of Avacopan Vifor following reassessment of benefit-risk balanceMHRA regulatory reform amendments tabled in Government’s Health BillSummary Basis of Decision for LeqembiFDA approves first‑in‑class Mimrylo (rusfertide) for polycythemia veraFDA Approves First Oral Drug for Dermatomyositis in AdultsFDA Issues EUA for Generic Ivermectin Injection to Prevent New World Screwworm in CattleFDA Approves First in Class Targeted Therapy for Metastatic Pancreatic CancerIncreased risk of wear and corrosion identified with certain cobalt chrome modular neck hip replacementsFDA Authorizes First Wearable Device That Continuously Monitors Both Ketone Levels and Blood SugarMHRA sets out position on regulation of microbiome-based medicinal productsQualifying notice for OjemdaMHRA advises quarantine of medical devices supplied without appropriate conformity markingsVimseltinib (romvimza) approved for use in adults to treat tenosynovial giant cell tumoursUK first in Europe to authorise orforglipron for weight management and type 2 diabetesMHRA approves remibrutinib for adults with chronic spontaneous urticariaThousands of patients to benefit from new daily pill for serious heart condition following co‑ordinated MHRA and NICE decisionsMHRA clarifies regulatory status of ambient voice technologies used in the NHSCHMP issues July 2026 meeting highlightsHealth Canada launches draft guidance on Ministerial Reliance Order for human and veterinary drug submissionsPRAC meeting highlights 6–9 July 2026CHMP meeting highlights 22‑25 June 2026Summary Basis of Decision for VoxzogoSummary Basis of Decision for EydenzeltSummary Basis of Decision for RedemploSummary Basis of Decision for ZiiheraSummary Basis of Decision for TryngolzaEMA, AMA and African regulatory authorities join forces on Ebola outbreak responseETF recommends updating COVID-19 vaccines to target XFG variantGuidance on nitrosamine impurities in medications updatedEMA CHMP opinion recommends authorisation of Jascayd (nerandomilast) for IPF and PPFEMA actively monitoring cruise ship Hantavirus outbreakEMA recommends authorisation of first veterinary vaccine using RNA technologyFinal notice: Classification of topical products containing human‑derived exosomes, extracellular vesicles, or cell‑conditioned mediaEMA consults on virtual control groups to help reduce animal use in medicines developmentEMA recommends restricting use of Tecovirimat SIGA