Approvals, CHMP opinions, FDA decisions, guidelines, designations and regulatory policy.
Ravimiamet has published an overview of authorisations that lapsed at holders' request, and every product shown in the available text is marked as not marketed.
MHRA scientists and the GSK Vaccines Institute for Global Health report that nasal or sublingual delivery of a GMMA-based Strep A vaccine produced immune responses in mice.
The latest monthly release adds to a series of transparency data on the agency's KPIs and expected timelines for specific regulatory functions, running since March 2025.
The UK regulator revised both its open and closed device exemption lists on 27 October 2026, continuing a run of near-weekly changes through the year.
The UK regulator updated its Access work-sharing guidance on 27 October 2026, adding icotrokinra to the table of products approved through the New Active Substance Work Sharing Initiative.
Manufacturers have pulled lots of Alyglo, Gammaked, Gamunex-C and Yimmugo after a higher rate of allergic reactions, some considered medically significant, FDA's biologics centre reports.
The US regulator has directed Takeda to add its most serious label warning to the recombinant ADAMTS13 therapy for congenital TTP after a postmarketing safety signal.
Updated Phase 1 data show a 45.5% confirmed response rate in 11 evaluable patients, alongside a high rate of serious related adverse events and three suspected dose preparation errors.
Aptevo says 10 of 47 evaluable newly diagnosed AML patients, initially unfit for intensive chemotherapy, reached allogeneic stem cell transplant after mipletamig plus venetoclax and azacitidine.
Laromestrocel did not improve right ventricular ejection fraction at 12 months, though a prespecified secondary analysis found one major adverse cardiac event against eight with standard care.
Portugal's regulator has exceptionally authorised an Irish-sourced, English-labelled latanoprost/timolol single-dose eye drop to limit the impact of the Monoprost Duo shortage.
The Neuroscience Advancement and Innovation Nexus will link three FDA centres, starting with an Alzheimer's Prevention Accelerator, while review decisions stay with individual centres.
Slovakia's medicines agency has published revised forms for human-medicine MA transfers, with the current and proposed holders' declarations now provided as separate annexes.
Implementing Regulation (EU) 2026/2348, dated 23 October 2026, amends Regulation (EU) No 540/2011 to prolong approvals for a long list of pesticide active substances and microbial strains.
Austria's regulator says it can inspect a third-country manufacturer only once an EU marketing authorisation dossier is submitted, or is submitted alongside the inspection, and advises early contact.
The Danish Medicines Agency reports production problems affecting Froidir 100 mg clozapine tablets, with disruption expected from mid-October to the start of December 2026.
EMA's human medicines committee recommended six products for approval, confirmed a refusal for narsoplimab and backed over-the-counter status for Nyxoid, according to SÚKL's summary.
The UK regulator has authorised Janssen-Cilag's once-daily oral IL-23 receptor blocker for adults and adolescents aged 12 and over weighing at least 40 kg.
The UK regulator approved the JAK inhibitor via the International Recognition Procedure for Sun Pharma UK. It later corrected the reported trial population to 1,209 patients.
Implementing Regulation (EU) 2026/2340 declines to approve an extension of use for Urtica spp. under the EU plant protection products framework, Regulation (EC) No 1107/2009.
A joint position paper from EMA's Emergency Task Force and the AMA sets minimum requirements and design advice to speed clinical trials of vaccines against Bundibugyo virus.
Spain's medicines agency says the product sold as 'natural' contains an undeclared PDE-5 inhibitor, which makes it a medicine in law, and has ordered it off the market.
Italy's medicines agency says monitoring of Raxone in LHON stops on 22 October 2026, following publication of Determina DTS 54/2026 in the Official Gazette.
Industry associations and the medical devices market surveillance authority discussed how to speed up and clarify applications for Certificates of Free Sale, with practical guidance floated as a next step.
Italy's medicines agency has closed registry monitoring for idelalisib in chronic lymphocytic leukaemia and follicular lymphoma, following publication of Determina DTS 56/2026 in the Official Gazette.
Italy's medicines agency has closed monitoring in the COMETRIQ (cabozantinib) registry for its sole listed indication, following publication of a determination in the Official Gazette.
Italy's medicines agency says monitoring of crizotinib in advanced ROS1-positive non-small cell lung cancer stops on 22 October 2026, following publication of a determination in the Official Gazette.
The Neuroscience Advancement and Innovation Nexus will coordinate drug, biologic and device expertise on brain and nervous system conditions, starting with an Alzheimer's Prevention Accelerator.
Spain's medicines agency has begun work on IPTs for products with a positive CHMP opinion in September 2026, with a marketing-intention step for new medicines.
Spain's medicines agency says the labelling allowed several large body areas to be treated in one day, exceeding the exposure assumed in the safety assessment; the product is back on sale with a new warning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.