Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
Italy's medicines agency has revised the HETRONIFY registry for serplulimab in extensive-stage small cell lung cancer, following a determination published in the Official Gazette on 21 October 2026.
Italy's medicines agency says monitoring of panobinostat (Farydak) in its registry stops on 22 October 2026, following a determination published in the Official Gazette the day before.
Italy's medicines agency says monitoring of Raxone in LHON stops on 22 October 2026, following publication of Determina DTS 54/2026 in the Official Gazette.
Industry associations and the medical devices market surveillance authority discussed how to speed up and clarify applications for Certificates of Free Sale, with practical guidance floated as a next step.
The Austrian regulator lists Northern Burgenland, Vienna and northern Vienna surroundings as regions with confirmed locally acquired West Nile virus infections.
Austria's medicines authority has added a levofloxacin entry, covering intravenous and oral forms, to its PV template-text page, directing readers to CMDh meeting minutes.
Italy's medicines agency has closed registry monitoring for idelalisib in chronic lymphocytic leukaemia and follicular lymphoma, following publication of Determina DTS 56/2026 in the Official Gazette.
Italy's medicines agency has closed monitoring in the COMETRIQ (cabozantinib) registry for its sole listed indication, following publication of a determination in the Official Gazette.
Italy's medicines agency says monitoring of crizotinib in advanced ROS1-positive non-small cell lung cancer stops on 22 October 2026, following publication of a determination in the Official Gazette.
Germany's BfArM has listed a manufacturer safety notice for BioFire Diagnostics' FilmArray Torch, but the listing gives no details of the issue or the actions required.
Germany's regulator has published a manufacturer advisory covering two Beckman Coulter centrifuge rotor assemblies, though the listing itself gives no detail on the problem or the actions required.
Germany's medicines and devices authority has posted a manufacturer advisory covering the Diomni Software, an in-vitro diagnostic product, though the published listing does not describe the underlying issue.
German regulator BfArM has published a manufacturer field safety notice covering Steriflush pre-filled water syringes, but the listing itself gives no details of the defect or affected lots.
Czech regulator SÚKL has temporarily shut its electronic vigilance reporting interface following a NÚKIB warning about a PHP vulnerability, while reporting duties remain in force.
US prosecutors allege sham addiction treatment, unnecessary atherectomies that injured patients, hospice fraud and bogus pharmacy prescriptions, in a case that includes six medical professionals.
The Neuroscience Advancement and Innovation Nexus will coordinate drug, biologic and device expertise on brain and nervous system conditions, starting with an Alzheimer's Prevention Accelerator.
Spain's medicines agency has begun work on IPTs for products with a positive CHMP opinion in September 2026, with a marketing-intention step for new medicines.
Spain's medicines agency says indirect contact with treated owners can cause severe cardiovascular toxicity and death in companion animals, and urges vets and prescribers to report cases.
Spain's regulator says French tests found 7.6% hydrogen peroxide in the TEMU-sold cosmetic, against a 0.1% limit for oral products.
Italy's medicines agency has revised the eligibility form for serplulimab in first-line ES-SCLC, following publication of Determina DTS n. 57/2026 in the Official Gazette.
Italy's medicines agency says monitoring for Raxone in LHON stops on 22 October 2026, following publication of Determination DTS n. 54/2026 in the Official Gazette.
Italy's medicines agency says monitoring of the Farydak registry stops from 22 October 2026 for its sole listed indication, following a determination published in the Official Gazette.
Spain's medicines agency says the labelling allowed several large body areas to be treated in one day, exceeding the exposure assumed in the safety assessment; the product is back on sale with a new warning.
Spain's medicines agency has started work on therapeutic positioning reports for products with positive July CHMP opinions, with marketing-intention notices from holders determining when new-medicine reports begin.
The Dutch health inspectorate has published a manufacturer warning on a Patient Lifting Solutions trolley coupling, where a weld below specification may let the blocking arm detach.
The Dutch inspectorate has published Abbott's field safety notice on the FreeStyle Libre 3 and Libre apps, with a corrective app update still being prepared.
Germany's medicines and devices authority has published a Boston Scientific field safety notice for OptiCross, but the listing itself does not describe the problem or the action required.
Houston Rx's tirzepatide and niacinamide 2 mL vials are being recalled nationwide in the US because sterility cannot be assured, and the recall is ongoing.
The recall of Zydus Pharmaceuticals (USA) Inc's hydrocortisone sodium succinate for injection, logged as D-0039-2027, is ongoing and covers nationwide distribution within the United States.
The recall, numbered D-0042-2027 and still ongoing, is classified as Class II and covers US nationwide distribution, according to the FDA enforcement report.
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.