Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
Preliminary, unaudited figures show wholesalers bought 792 units of the cutaneous T-cell lymphoma therapy in the September quarter, against 360 in the previous quarter.
Acumen Pharmaceuticals expects topline results from its 542-patient Phase 2 trial of sabirnetug in early Alzheimer's disease next month, with ARIA rates among the safety measures.
Initial PrisMN data presented at ASN Kidney Week show PLA2R antibody reductions and early remissions with the anti-CD19 antibody, with no treatment-related serious adverse events reported.
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.
Nasdaq-listed DataMEDS AI has signed a revised letter of intent with five counterparties, targeting a Q4 2026 close, though the deal remains subject to definitive agreements and several approvals.
Pro forma financials for a merger agreed on 14 July 2026 show Senti Biosciences Holdings with about $3.1 million in cash after handing its operating units to ST NewCo Limited.
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.
CBER says Ebola transmission through cells and tissue products has never been described, but suggests establishments consider 21-day exposure and travel history for donors during the Bundibugyo outbreak.
CBER has pushed the expiry of the only US-licensed coral snake antivenin lot from 30 June to 31 December 2026, citing stability data.
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.
The Slovenian agency's latest bulletin for healthcare professionals covers a change in the formulation and preparation of Amoksiklav oral suspension and the mechanisms behind adverse drug reactions.
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.
Italy's medicines agency has issued updated lists of reimbursed and hospital-use products, ordered by active ingredient and trade name, to support prescribing by active substance.
EOF has published a recall decision covering a batch of BLAYCO Electrode tip cleaner and DORMO-STRIP Vein strippers, both made by TELIC S.A.U.
Ravimiamet's laboratory has been formally attested by the European OMCL network following an international Mutual Joint Audit assessing its quality system against ISO/IEC 17025 and network requirements.
The Danish Medicines Agency says Cheplapharm's Zyprexa 10 mg powder for solution for injection is affected by production problems, with disruption expected from October to the end of November 2026.
The Danish Medicines Agency lists Orifarm's olanzapine powder for solution for injection as affected by delivery difficulties, with no end date given.
The Danish Medicines Agency reports delivery difficulties affecting olanzapine injection powder, with disruption expected from early September to early November 2026.
The Danish Medicines Agency reports delivery difficulties with olanzapine powder for solution for injection from Paranova Danmark ApS, with no end date given.
DKMA says delivery difficulties are affecting Prizapin 100 mg tablets from Nordic Prime ApS, with the expected end of the disruption listed as unknown.
DG SANTE has revised its procedural guidance for HTA joint scientific consultations on medicines and on medical devices and in vitro diagnostics, introducing a role described as 'watcher'.
The UK regulator's eleventh annual campaign runs from 2 to 8 November 2026, urging suspected side effect and device incident reporting, alongside NHS login integration and a progressive web app.
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.
Italy's medicines agency has issued updated reference tables of NHS-dispensed Class A and Class H products, supporting prescribing by active substance and noting an equivalence code change for amiodarone injection.
Krascendo 1 data presented at ESMO show divarasib cut the risk of death by 44% in previously treated KRAS G12C-mutated NSCLC versus the two approved inhibitors.
The Dutch inspectorate IGJ has published a manufacturer field safety notice covering Philips' Lumify diagnostic ultrasound system, citing issues that could prevent or slow scanning.
Spain's regulator says some LUNA X5 carriages used in portable configuration with an extension arm may not lock fully, risking a hoist fall and injury during patient transfers.
Interim IMAgINATION results presented at ASN Kidney Week show a proteinuria reduction at week 37 and no new safety signals, with eGFR data still to come.
The outcome of PSUSA/00001026/202512 for diacerein is a regulatory variation, with CMDh conclusions and product information amendments published on 23 October 2026.
Commission Decision (2026) 7741 of 23 October 2026 withdraws the authorisation for Trizivir (abacavir/lamivudine/zidovudine); the reason is not stated in the available source.
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.