Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
A safety review committee has recommended moving Azitra's ATR-04 Phase 1/2 trial to Cohort 2, as the company reports a $3.0 million third-quarter net loss.
The US biotech says SOLARA-2, a single-arm study in EGFR C797S-positive NSCLC, should dose its first patient in Q1 2027 and could support an accelerated approval filing.
Eledon reports Q3 2026 results, with US regulatory milestones in islet cell and kidney transplantation and $69.7 million in cash funding operations into Q2 2027.
The cell therapy developer reported that laromestrocel missed its primary endpoint in infants with hypoplastic left heart syndrome, and is now weighing a sale or merger.
The designation covers metastatic pancreatic adenocarcinoma, as Erasca reports $947.8M in cash at Q3 2026 after a July public offering of about $632.5M.
Ensysce's Q3 report shows the psilocybin-based CY200 Phase 2a protocol is under UK review, with the MHRA and an ethics committee requesting further information.
Armata Pharmaceuticals also reported Q3 2026 net income of $54.9 million, driven by a loan fair-value gain, while it finalises its Phase 3 protocol with the FDA.
Interim NEXICART-2 data in relapsed/refractory AL amyloidosis will go to ASH in December, as Immix confirms a mid-2027 FDA filing plan and cash into mid-2028.
The gene-editing company's unaudited interim accounts show a sharp fall in revenue, higher research spending, lower cash and negative shareholders' equity at 30 September 2026.
The gene therapy developer says the FDA agreed the pivotal Phase 2 design for RP-A501 and that KRESLADI is commercially ready, with cash expected to last into Q3 2028.
Candel Therapeutics now expects to file its aglatimagene besadenovec application in mid-2027, citing assay refinement timelines, and reports cash of $203.1 million.
In its fiscal 2026 results, Arrowhead reported growth in the US Redemplo launch for FCS and an sNDA for sHTG, with a US launch targeted for Q2 2027.
The US neurology company named four late-stage assets and said it is building commercial readiness across epilepsy, movement disorders, neurodevelopment and pain.
The renamed Nasdaq-listed company says its oral colon-targeted AhR agonist for ulcerative colitis remains on course for an IND filing and Phase 1a start in the first half of 2027.
The agency has approved a PMA supplement for the CGuard Prime 80 cm system in TCAR for high-surgical-risk patients, based on the 50-patient CGUARDIANS II trial.
The US cell therapy and devices company says it has completed the PMDA process on CardiAMP application materials, while FDA feedback on a revised Helix Pre-Submission is expected within weeks.
Anaptys posted $30.3 million in collaboration revenue for the September quarter, with a rectal cancer approval for Jemperli and a Delaware judgment and an FDA decision both approaching.
The US device maker reported Q3 2026 results, with FDA clearance for transcarotid use, a PMA supplement planned for December and a recalled delivery system due back in 2027.
Beaver-Visitec International has recalled certain Mini Blades units after finding an intermittent "open seal" condition that means sterility cannot be guaranteed, Health Canada reports.
Siemens Healthineers is issuing a delta-installation hotfix, XB20A-HF02, for seven MAGNETOM Flow.Elite scanners in Canada, addressing coil detection, logging, start-up stability and patient table reliability.
Health Canada has listed a recall of Centricity Universal Viewer software over a vulnerability that could allow unauthorised access to patient data when launched from third-party applications.
Novartis says remibrutinib 25 mg twice daily showed early, sustained efficacy to Week 52 in three chronic inducible urticaria subtypes, with results due at ACAAI 2026.
Nine General Procedure Tray configurations are affected after Becton Dickinson asked for discontinuation of infusion sets used with the BD Alaris pump module model 8100.
Siemens Healthcare's syngo MR XB10B-HF02 hotfix, covering two MAGNETOM Flow.Elite systems in Canada, addresses coil detection, data logging, start-up stability and patient table reliability.
Lab tests found Sphingomonas bacteria in an injectable peptide seized from Sage & Summit Wellness Co., and the regulator lists ten unauthorised injectable and oral products.
EMA's safety committee has opened an Article 31 review of all injectable iron products, assessing hypophosphataemia, osteomalacia and whether current risk-minimisation measures work.
DBV Technologies presented additional results from its 654-child VITESSE trial of the VIASKIN Peanut Patch at ACAAI in Phoenix, including severity of reactions and compliance.
The RNAi company reported a $12.4M third-quarter loss and $247.7M in cash, alongside positive Phase 2 divesiran data in polycythemia vera and a pending acquisition by Merck KGaA.
Lucid Diagnostics says Medicare is paying EsoGuard claims at the full fee schedule rate, with coverage granted case by case while a wider MolDX reconsideration remains pending.
The US device maker says its pivotal acute kidney injury trial is about 75% enrolled, while it advances a PMA submission and reports higher third-quarter Quelimmune sales.
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.