1. PRAC reviews hypersensitivity clusters linked to specific immunoglobulin batches
At its 26–29 October meeting, EMA's PRAC began assessing a safety signal: more hypersensitivity reactions than expected, ranging from rash to anaphylaxis and angioedema, linked to specific batches of human normal immunoglobulin medicines. Some batches of Flebogamma DIF, Yimmugo and Gamunex have already been recalled in certain EU Member States. Because no cause has been found yet, the review covers all human normal immunoglobulins, whether given intravenously, subcutaneously or intramuscularly. Marketing authorisation holders should expect a PRAC data request. Batch-level signal detection, lot traceability in case reports and cluster analysis across products will be central to the review. EMA PRAC meeting highlights, 30 Oct 2026
2. EU Article 31 referral opened for Deanxit (flupentixol/melitracen)
Belgium triggered an Article 31 review of the fixed-dose combination Deanxit, and PRAC started the procedure on 29 October 2026. The review follows reports of movement disorders and memory or thinking problems, some of which persisted after treatment was stopped. These effects are already in the product information, but the Belgian agency raised concerns about how severe and long-lasting they are and whether some may be irreversible. It also questioned the benefit of combining the two substances. PRAC will consider whether the national authorisations should be maintained, varied, suspended or revoked, and the CMDh will then adopt a position. It is a reminder that a known listed reaction can still prompt a full benefit-risk review when new information emerges on its severity or reversibility. EMA referral page, 30 Oct 2026
3. Partial clinical hold on two KITE-753 CAR-T trials over neurotoxicity differences
Gilead disclosed on 29 October that two trials of its anti-CD19/CD20 CAR-T candidate KITE-753 in diffuse large B-cell lymphoma, PALISADES-1 (phase 2) and PALISADES-2 (phase 3), are on partial clinical hold. Dosing was first paused voluntarily, and the company then aligned with FDA on the hold. The trigger was a difference between phase 1 and phase 2 in grade 3–4 immune effector cell-associated neurotoxicity syndrome (ICANS) in a small number of patients. The company reported no deaths or grade 5 events. The case shows why sponsors need to keep comparing safety across study phases as programmes scale up, rather than relying on early-phase profiles. Fierce Biotech, 30 Oct 2026
4. FDA extends mitapivat sickle cell review to assess whether a REMS is needed
FDA asked Agios for more information to decide whether a Risk Evaluation and Mitigation Strategy (REMS) is needed for mitapivat in sickle cell disease. It classed the company's response, which included updated open-label safety data, as a major amendment, moving the target action date from 1 November 2026 to 1 February 2027. Mitapivat already carries a boxed warning and a REMS for hepatocellular injury in its thalassemia indication. Agios reports no sickle cell cases with a similar pattern or severity of liver injury. This shows how a risk identified in one indication can shape the risk-minimisation requirements for the next. Agios press release, 30 Oct 2026
5. FDA removes more boxed-warning statements from menopausal hormone therapy labels
FDA approved updated labelling for three estradiol transdermal patch products from two applicants. The update removes statements on cardiovascular disease, breast cancer and probable dementia from the boxed warning, following similar changes to six products in February 2026. According to HHS, 29 companies have now submitted proposed labelling revisions. FDA says it is not aware of an imminent risk of a nationwide shortage but is working with manufacturers on supply. Safety teams with MHT products should follow the class-wide relabelling and expect possible changes in exposure and reporting patterns as use grows. HHS/FDA press release, 30 Oct 2026
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