Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
JAZMP reminds CGM users to follow manufacturers' instructions, cross-check unusual readings with a fingerstick meter and report suspected device problems, including near misses.
Three investigational medicines gain entry to the UK's Innovative Licensing and Access Pathway, with applications for the next round open until 11 February 2027.
The agency has released the draft guideline for stakeholder consultation, setting out its expectations for assays used to select patients for treatment.
The IGJ has posted an inspection report on Byondis B.V. following a supervisory visit in September 2026, but the listing does not give the findings.
The UK regulator's Innovative Licensing and Access Pathway, which joins regulators, HTA bodies and the NHS, was updated on 9 November 2026 and continues to accept entry applications.
Abiomed has reported more complaints that its Automated Impella Controller fails to detect the purge cassette, which it links to defects in a purge pressure sensor component.
A Brainlab field safety notice, published by Dutch inspectorate IGJ, says registration may fail or give unusable results in under-twos when Cranial EM is used with Universal Atlas 6.0.
IGJ has posted a manufacturer warning after market reports of abnormal waveforms and inaccurate physiological measurements, with an investigation pointing to gaps in Intersurgical's internal testing.
Baxter Healthcare is voluntarily correcting certain TruSystem 7000 and 7500 tables after customers reported the main lift falling to its lowest position during use.
Medtronic has released clinician programmer software 2.1.4148, which includes a firmware update addressing a previously reported fault in which the Vanta implantable neurostimulator stops working after cardioversion.
The Dutch health inspectorate has published a manufacturer warning: the Master List supplied with one Panocell-20 lot lists cell 6 as Jk(b+) when it is actually Jk(b-).
Philips Medizin Systeme Böblingen has issued a field safety notice after finding its Dual IBP Adapter cannot keep defibrillation protection when two non-defibrillation-proof transducers are connected together.
Version 2.0.3155 or later of the SynchroMed A820 myPTM app addresses delays reported by patients using the PTM with SynchroMed II and III infusion pumps.
The Dutch inspectorate has published a manufacturer warning on Inpeco's FlexLab X lab automation system, citing possibly under-tightened electrical clamp connections on internal power cables.
IGJ has published a manufacturer warning after Beckman Coulter rotors used in Optima ultracentrifuges were found with an abnormal microstructure that may cause breakage in use.
The Dutch inspectorate IGJ has published a Philips field safety notice saying some Azurion image-guided therapy systems may have been fitted with solid-state drives not listed in the medical device file.
Customers reported ammonia results reading about 6% to 15% low after switching standard lots, with the manufacturer warning of possible serious patient harm.
IGJ has published a manufacturer field safety notice after complaints that vacuum tubing in the cell rinse unit of the cobas c 303 deteriorated earlier than expected.
The manufacturer has begun a field safety corrective action after customers reported ammonia calibration results roughly 6% to 15% too low following a switch of standard lots.
SÚKL says falsified Mounjaro (tirzepatide) batches reported by Brazil's regulator have not been identified in the Czech market, and has asked operators to report any sighting immediately.
The Czech medicines authority says counterfeit Mounjaro detected abroad has not been traced in the Czech market, and asks operators to report any sighting of the listed batches immediately.
CBER is assessing whether regulatory action is needed after postmarketing malignancy reports, and says the neoplasia risk applies to both onasemnogene abeparvovec products, Zolgensma and Itvisma.
Spain's regulator says a motor shaft break combined with a faulty Single Fault Safety system could cause patient falls or sudden descents; Baxter is inspecting affected units.
Lab testing of products from Shanghai ERP Peptide Biotechnology found bacterial contamination, prompting seizures from two Canadian web retailers and a request that the supplier stop selling into Canada.
Interim results from six patients met the primary and key secondary endpoints, while the FDA and EMA granted regulatory designations for QRX003 in Peeling Skin Syndrome.
Health Canada has published a Type II recall of Sysmex CN-3000 and CN-6000 analyzers after deposits on the sample arm B probe were found to risk reduced sample volumes.
The lid lock on some ROTOFIX 32A centrifuges may not engage securely, leaving the handle bar or latch open during a run, according to Health Canada.
Intersurgical is recalling several lots of Smoothbore-based breathing systems in Canada after market reports of soft connectors coming off the tube, with insufficient bonding solvent identified.
The US oncology-focused biotech has bought a Phase 2-ready selective JAK1 inhibitor and a preclinical PKCθ programme for undisclosed cash, with no future royalties or milestones owed to Aqilion.
The registrational lymphatic malformations trial is now due to finish enrolling in early Q1 2027, with a rolling BLA planned for the second half of 2027.
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.