Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
Praxis Precision Medicines reported Q3 2026 results, with FDA decisions on relutrigine and ulixacaltamide due by 27 December 2026 and 29 January 2027 respectively.
Ionis lowered its full-year Tryngolza outlook, citing slower-than-expected uptake in severe hypertriglyceridemia, while reaffirming other guidance and launching Zanvastro in Alexander disease.
The company says its 505(b)(2) filing for AXPAXLI remains on track after a September FDA meeting, with the SOL-R primary endpoint moved to Week 40.
Roivant's fiscal Q2 update covers early sales of FDA-approved LISRAYA, an uveitis filing plan, a positive rheumatoid arthritis readout for IMVT-1402 and a Phase 3 start for mosliciguat.
The gene-therapy maker reported 15 patients treated since launch, an eight-site QTC network and one batch that failed its identity assay release criterion.
The agency has published Revision 1 of its draft guideline on assessing medicinal products' risks in human reproduction and breastfeeding, covering the path from data to product information.
Internal validation of replacement batteries revealed the ROTAFLOW Console can stop charging its battery once battery operation mode has been used, according to a manufacturer warning published by Dutch regulator IGJ.
The manufacturer is revising the instructions for use of its OptiCross intravascular ultrasound imaging catheters, according to a field safety notice published by the Dutch inspectorate IGJ.
IGJ has published a manufacturer warning for exocad's exoplan planning software after a dentist found one implant, sleeve and drill combination could drill 2.0 mm deeper than expected.
The Dutch health inspectorate IGJ has posted a manufacturer warning saying the Altair ceiling lift's strap clip can contribute to localised strap wear or damage under certain conditions of use.
The Dutch inspectorate IGJ has published a manufacturer field safety notice covering the Aerogen Solo Continuous Nebulization Tube Set, citing incorrect enteral syringes in some products.
The Dutch inspectorate has published a manufacturer field safety notice on unintended stimulation during charging, or failure to charge, with the Evoke CLS.
The Dutch inspectorate has published a manufacturer field safety notice asking for preventive speed limiting on all Batec Handbikes platform 2 models, citing a new version of EN 12184.
Asundexian 50 mg tablets are cleared alongside antiplatelet therapy after a recent non-cardioembolic ischaemic stroke or high-risk TIA, with bleeding data shaping the label.
The agency's 4 June 2024 digest covers further recalls of China-made plastic syringes, a Cronobacter safety alert for an infant formula, and a CDER explainer on pharmaceutical quality.
The FDA has upgraded its Early Alert on Presource convenience kits containing BD Alaris Pump infusion sets to a Class I recall, its most serious category.
The German regulator has posted an urgent field safety notice from Tontarra Medizintechnik covering a yellow ceramic-tip endoscope inner sheath, but the details sit in the manufacturer's own advisory.
Germany's regulator has posted a manufacturer advisory on the haematology reagent, but the defect and required user actions appear only in the attached Beckman Coulter notice.
Eugia US is recalling one lot of vancomycin for injection to hospital level after a glass particle was identified inside a vial; no adverse events have been reported.
The US Centers for Medicare & Medicaid Services has distributed $10bn across all 50 states in the second year of its programme to strengthen rural healthcare.
INFARMED has granted hospital use of dostarlimab with carboplatin and paclitaxel for advanced or recurrent pMMR endometrial cancer and published its public assessment report on Infomed.
The regulator has refreshed its Innovative Licensing and Access Pathway page, which joins developers, regulators, HTA bodies and the NHS in one route, but the source does not say what changed.
The Danish Medicines Agency will deactivate its section 29(2) permission for German-authorised Paracetamol AL "Aliud" suppositories because marketed Danish packs are available again.
The Danish Medicines Agency says Teva Denmark is facing delivery difficulties with Pinex 500 mg suppositories, with foreign packs permitted as a substitute under section 29(2) of the Medicines Act.
The Danish Medicines Agency lists delivery difficulties for paracetamol suppositories and points prescribers to foreign packs under section 29(2) of the Medicines Act.
Austria's medicines agency has published a pharmacovigilance FAQ entry on how marketing authorisation holders should respond when asked to add safety wording that their product information already contains.
Austria's regulator has added a standard SCAR text to its safety-wording page, pointing to CMDh minutes from the September 2026 meeting.
Greece's EOF has published a notice that the marketing authorisation holder will permanently stop marketing EMEND (aprepitant), with Greece named among the affected countries.
The National Organisation for Medicines has issued a corrected repeat of its 31 October 2026 list of medicinal products with limited availability on the Greek market.
The Danish Medicines Agency is inactivating its section 29(2) exemption for German-authorised Paracetamol AL 'Aliud' suppositories, as marketed Danish packs are available again.
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.