Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
Germany's regulator has listed a manufacturer advisory on the Rotaflow Console, but the public entry does not describe the fault or the corrective actions required.
FDA's device centre has flagged a potentially high-risk issue after B. Braun found a missing solvent step left some dialyzer connectors inadequately bonded in three lots.
Roche says its benchtop cobas smart e immunoassay platform, planned to offer over 100 assays, can bring central-lab-comparable results to smaller laboratories and clinics.
The US hospital operator says people losing exchange coverage cut pre-tax income by about $400m, yet it expects 2026 results in the upper half of guidance.
The contract research and analytics group reported $3.2bn in R&D Solutions net new bookings, while a review of inactive trials trimmed its contracted backlog by about $2.1bn.
The bioprocessing supplier reported third-quarter sales of $209.3 million, up 11%, and said the BioLife deal extends its reach into cell therapy consumables.
The insulin pump maker plans to resubmit its dosing algorithm in mid-Q4 2026 with added simulator data, while winning FDA clearance for Mint.
Wave Life Sciences says the FDA has aligned with a one-year interim analysis on AATD biomarkers that could support accelerated approval of its RNA editing therapy WVE-006.
Aclaris says its anti-TSLP/anti-IL-4Rα bispecific cut EASI scores by 58% versus 13% on placebo at day 57 in atopic dermatitis, from small cohorts.
Updated Cohort 4 data from the GOBLET study show median duration of response of about 15 months in second-line or later squamous cell anal cancer, with median overall survival not yet reached.
The company reported $286.0m in third-quarter ARCALYST net revenue and lifted its full-year outlook, while confirming timelines for its KPL-387 and KPL-1161 pipeline programmes.
The company says all five patients tested PCR-negative after tafenoquine-based combination therapy, and plans a pre-sNDA FDA meeting after unblinding its randomised hospital study in January 2027.
The Danish Medicines Agency has surveyed public behaviour and attitudes towards online medicine purchases, finding sensible habits but limited knowledge of the sales rules.
The agency has updated its blood and tissue safety notice, asking establishments to take the affected areas into account during donor interviews and selection.
The agency's 27 October blood and tissue safety update names the Dutch areas with confirmed human cases and asks that they be considered in donor interviews and selection.
Austria's BASG has issued an updated safety notice naming Italian municipalities with confirmed locally acquired dengue cases, asking blood services to take them into account at donor selection.
Austria's health safety authority lists three French départements and five overseas départements with confirmed locally acquired dengue, asking blood and tissue services to take this into account in donor screening.
BASG reports a pharmacy-level recall of one Viatris Austria batch of vitamin D3 and calcium chewable tablets because several serial numbers were never uploaded.
The draft introduces existing resources for electronic IDE submissions; binding standards, a timetable and exemption criteria are due only when the guidance is finalised.
CBER's updated guidance page lists documents issued between July and October 2026, including a draft on individualised human genome editing products and blood donor compliance policies.
CBER says Beaute Bounty's website markets embryonic stem cell and placenta-derived products with disease claims, without the approved biologics licence the agency requires.
CBER says the company's stem cell and exosome IV offerings are unapproved new drugs and unlicensed biological products, and that the umbilical cord product is not a homologous-use HCT/P.
FDA has posted the agenda and slides from its 26 October meeting on proposed recommendations for renewing the Biosimilar User Fee Act, with a docket open for comments.
CBER's guidance listing for cellular and gene therapy products shows seven 2026 entries, the latest a draft on individualized genome editing products dated October 2026.
FDA's biologics centre has posted a draft guidance on individualised genome-editing products, new blood donation compliance policies, immune globulin lot withdrawals and a run of approval documents.
Merit Medical has issued a field safety notice, published by the Dutch inspectorate, over resistance when Philips Bridge balloons are advanced over the guidewire in the Bridge Prep Kit.
The Dutch health inspectorate says the latest app version addresses a previously reported vulnerability and a signal-loss problem some users had after the previous update.
The German regulator has published a manufacturer safety notice for the 6008 CAREsystem, but the listing itself does not describe the hazard or the corrective actions.
Ravimiamet's October 2026 overview of veterinary approvals lists one product: Bioveta's BioBos BTV 3 injectable suspension, authorised on 26 October with a one-year validity.
Ravimiamet has published an overview of authorisations that lapsed at holders' request, and every product shown in the available text is marked as not marketed.
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.