Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
The US life-sciences services group has signed an exclusive licence and made an acquisition to widen GENEWIZ's gene synthesis offering for antibody discovery, protein engineering and AI-enabled drug discovery.
The antibody discovery company reported third-quarter revenue of $4.0M and a $15.7M net loss, while lifting full-year revenue and year-end cash forecasts.
Acumen Pharmaceuticals says ALTITUDE-AD failed on its primary iADRS measure at both doses, and the company will end work on the amyloid antibody and explore strategic options.
Regeneron reports $5.1bn third-quarter revenue, widens its Sanofi antibody collaboration with a $1.0bn up-front payment, and notes FDA approval of Pasatru for fibrodysplasia ossificans progressiva.
The EU regulator's single assessment of periodic safety update reports for the dimeticone and guaiazulene combination ends with a 'maintenance' outcome, and a list of nationally authorised products has been published.
The EMA has published a PSUSA outcome for pooled, virus-inactivated human plasma, with the regulatory result recorded as 'maintenance'.
The EMA has published the periodic safety update report single assessment for ethosuximide, with a regulatory outcome of 'maintenance' and a list of nationally authorised products.
The US home and community health and pharmacy group reported higher third-quarter earnings, lower leverage and an upgraded full-year outlook following the March sale of its Community Living business.
CBER has cleared Inovio's Voceryq for adults with RRP on a surgery-frequency endpoint, with post-approval trials required to confirm clinical benefit.
Portugal's medicines authority says limited stock for prescription dispensing in community pharmacies reflects a European shortage, and recommends that valid prescriptions be accepted.
Germany's medicines and devices authority has published a Philips Medical Systems Nederland field safety notice for Azurion, but the nature of the issue sits only in the manufacturer's attached advisory.
Germany's BfArM has listed an urgent field safety notice from Intersurgical Ltd. for its Smoothbore Breathing System, with all substantive details held in the manufacturer's attached advisory.
Nova Biomedical's Gen 2.0 hospital meters can retain prior patient or QC information on screen, risking results being filed to the wrong record; a software fix is planned for November 2026.
The Czech medicines authority has published its November 2026 list of individually prepared medicinal products, incorporating two general-nature measures on radiopharmaceuticals and an advanced therapy medicinal product.
The Medical Device Coordination Group has issued a revised position paper on managing the Summary of Safety and (Clinical) Performance in Eudamed once the system's use becomes mandatory.
Italy's medicines agency recorded no new innovativeness recognitions for September 2026 and named two oncology products that failed to meet the criterion.
DKMA's supply notice says GlaxoSmithKline Pharma A/S will end marketing of Flolan 1.5 mg epoprostenol infusion powder for commercial reasons, with the withdrawal expected from late December 2027.
GlaxoSmithKline Pharma A/S will end marketing of the epoprostenol infusion product in Denmark for commercial reasons, the Danish Medicines Agency has announced.
The UK regulator has authorised an oral liquid triheptanoin for adults and children with LC-FAOD, pending further efficacy and safety evidence from an ongoing paediatric study.
Italy's medicines agency recorded no new innovativeness recognitions for September 2026, while confirming that belantamab mafodotin and inavolisib were refused the status for their assessed indications.
The guidance, issued through CBER and CDER, outlines a nonclinical testing strategy for QT-related risk, including assays and integrated risk assessment, and may be revised as data accumulate.
Italy's medicines agency says problems with automatic mapping of EudraVigilance ICSRs to its national network prompted a reminder on completing two key E2B(R3) fields uniformly.
AIFA says the EMA safety committee started an assessment of hypersensitivity reports linked to specific normal human immunoglobulin batches and a review of Deanxit at its October meeting.
DKMA says Elanco Denmark's tiamulin-based veterinary oral solution is in short supply, with disruption expected from late April to mid-November 2026 because of increased sales and demand.
The medicines agency says Lenzetto spray should return progressively from mid-November, while some transdermal patches stay hard to obtain because of demand pushed up by the shortage.
Italy's medicines agency says problems with automatic mapping of EudraVigilance cases to its national network prompted a reminder on how to complete product name and active substance fields.
Kwame Raoul says the defendant took nearly $10,000 from Illinois for services never provided, in a case linked to a nationwide healthcare fraud enforcement action.
EMA's safety committee will examine all normal human immunoglobulin products, whatever the route of administration, after more hypersensitivity reports linked to specific batches, according to ŠÚKL.
The Paul-Ehrlich-Institut has let STADA supply Hukyndra 40 mg pre-filled pens in Finnish, Swedish, Norwegian and Danish packs in Germany to secure patient supply.
Czech regulator SÚKL has told distributors and healthcare facilities to withdraw a specified batch of Nitromint 2.6 mg modified-release tablets; patients need not return packs.
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.