Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
The IGJ has released a supervisory inspection report on Asclepius Pharma BV, but the material available gives no details of its findings or any required corrective measures.
The Health and Youth Care Inspectorate has posted its supervisory report on the Amsterdam donor sperm bank, though the notice itself does not reveal findings or any enforcement.
EOF has issued a supplementary recall covering batches 489588, 493006 and 497199 of Pedmarqsi 80 mg/ml solution for infusion, adding to an earlier recall.
The report on camizestrant (Etcamah), prepared by Austria and Belgium under the EU HTA Regulation, will feed into national decision-making by Member States.
The report on camizestrant (Etcamah), assessed by Austria and Belgium under the EU HTA Regulation, was endorsed by Member States on 19 August 2026.
The IGJ has released a report on its February 2026 supervisory visit to Stichting Sanquin Amsterdam, but the available description does not set out the findings.
AEMPS says its veterinary committee gave favourable opinions on four marketing authorisation applications on 14 October; formal authorisation decisions are still to be issued by the agency's management.
Spain's medicines agency has published its October 2026 CHMP bulletin, listing three positive opinions for new medicines and five changes to products already authorised in the EU.
The UK regulator's guidance page, last updated 6 November 2026, sets out the 60-day notice rule, fees and payment steps for sponsors planning device studies.
The UK regulator's new guidance sets out key regulatory steps for placing SaMD on the market in Great Britain and Northern Ireland, but describes itself as a starting point only.
The UK regulator's page, last updated 6 November 2026, sets out risk-based and triggered inspections, dossier requests and the inspection process, with ICH E6(R3) as the reference standard.
Denmark's medicines agency says Aspen Nordic is struggling to deliver the lidocaine gel, with disruption expected from mid-July 2026 until the end of March 2027.
The regulator's first list covers products whose global marketing authorisations began between 2014 and 2021, with further additions and periodic updates promised.
The UK regulator's new guidance sets out key regulatory steps for SaMD manufacturers targeting Great Britain and Northern Ireland, from qualification and classification to MHRA registration.
A Dutch IGJ notice reports that Bolton Medical's internal review found about 1% of units may exceed the endotoxin specification, prompting a field safety notice.
IGJ reports that the stent's sterile packaging failed a microbial barrier test after five years of real-time aging, leaving its claimed five-year shelf life unsupported.
The UK regulator proposes more frequent ECG and electrolyte checks for givinostat, with implementation subject to an ongoing independent review; no deaths have been reported in the UK.
The MHRA and several EU regulators and ethics committees have authorised sites in the Phase 1/2 ASCEND study, with first dosing still expected by the end of 2026.
Health Canada lists a Type II recall after replacement monitors shipped without the required VGA cable, so engineers may have fitted cables of unknown origin.
Nova Biomedical's StatStrip Ketone Test Strips, model 66841, are being recalled in Canada after affected lots showed more quality control failures during use, though patient blood results are unaffected.
Health Canada has posted a Type II recall covering a syngo.via MR Flow Quantification issue when Beat Sensor triggering is used for retrospectively gated 2D cardiac flow scans on the MRI system.
The Nasdaq-listed sidewalk and hospital robot company also cut its non-GAAP operating expense outlook and launched a service offering its technology to other robot makers.
Elicio Therapeutics says pre-specified subgroup analyses from AMPLIFY-7P will shape Phase 3 design, despite the trial missing its primary disease-free survival endpoint in the overall population.
NeOnc Technologies posted a Q3 2026 net loss of $4.4M and flagged Phase 2a NEO100 results, FDA feedback on NEO212 and a $15M registered direct offering.
The long-term care pharmacy provider reported $371.1 million in third-quarter revenue, higher net income and adjusted EBITDA growth of 24%, and raised its full-year guidance.
The gene-editing company says it will discontinue clinical development of vispa-cel and CB-011 and is exploring alternatives, including a merger or liquidation, after a difficult financing climate.
The US diagnostics company reported quarterly revenue of $24.0 million, with Diagnostic Testing up 16%, but cited sales force changes, seasonality and delayed development projects.
The US cell therapy developer says its cash runway extends into mid-2027 and that SC451, a hypoimmune islet therapy for type 1 diabetes, could enter the clinic as early as this year.
Two Phase 3 EMBARQ studies in chronic spontaneous urticaria met all primary and key secondary endpoints, while the company drops its Phase 2 prurigo nodularis study.
The aortic disease specialist posted a $7.9M net loss and lower adjusted EBITDA, while preparing a January 2027 US launch of NEXUS.
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.