Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
AEMPS's Veterinary Medicines Availability Committee updated its priority-needs document, adding new active-substance needs and removing others now covered by authorised products.
Spain's regulator says a gap between bed and handle may trap users; manufacturer Trust Care AB has paused sales and revised the instructions for use.
Italy's medicines agency has published a DHPC after reports that the metal seal on certain Caelyx vials may not be firmly fixed, risking sterility and occupational exposure.
The Czech regulator has told distributors and healthcare facilities to withdraw a specified batch of Betadine 30 g ointment; patients are not asked to return packs.
The Czech regulator has published a marketing authorisation holder's letter on a quality defect in Caelyx pegylated liposomal 2 mg/ml, 1 x 25 ml, involving a stopper and closure that could come loose.
The UK regulator has widened Casgevy's licence from patients aged 12 and over to eligible younger children with severe sickle-cell disease or transfusion-dependent β-thalassaemia.
Italy's medicines agency has published a quality DHPC after reports that the aluminium ferrule on some Caelyx/Doxil 50 mg/25 mL vials was improperly sealed, risking sterility and operator exposure.
Council Decision (EU) 2026/2471 fixes the EU stance for the Joint Committee on amending provisions that implement the veterinary protocol to the EU–Denmark/Faroe Islands Agreement.
Germany's two medicines safety authorities join the international social media campaign, which urges patients and health professionals to report suspected side effects rather than ignore them.
Following a June inspection at its Montagny site, France's regulator has set deadlines of one to six months for correcting five unresolved MDR non-conformities.
The Council has fixed the EU's stance for the Joint Committee under the EU–Denmark/Faroe Islands Agreement, covering changes to provisions implementing the Protocol on veterinary matters.
The agency has reissued its draft guidance on delivery performance information for drug-delivery devices and combination products, replacing the version announced in July 2024.
Estonia's State Agency of Medicines (Ravimiamet) announced that, by decision of its Director General, changes were made to the register of activity licences (manufacturing/wholesale authorisations) in October 2026. The input does not specify which licences were affected, so QA professionals should check the register directly for any impact on their supply chain partners.
VB Spine reports ES2 Spinal System Nitinol K-Wire Blunt devices have broken during removal from patients, with 16 complaints worldwide so far, according to Dutch inspectorate IGJ.
Medline is discontinuing all its branded beds and accessories, with repair, replacement or refund offered, after reports of two deaths and 16 serious injuries linked to fire and entrapment hazards.
The spine surgery company blamed weaker biologics attachment for the shortfall and now expects full-year revenue of about $862 million.
Merit Medical bought the remaining equity in Solo Pace, its exclusive distributor partner, bringing the FDA-cleared SOLO PACE CONTROL and FUSION pacing systems in-house.
Updated Phase 2 data show a markedly higher response rate in KRAS wild-type NSCLC, and the company is discussing a 2027 sBLA with the FDA.
The packaging and drug-delivery supplier reported 1% core growth in Pharma, or 8% excluding emergency medicine destocking, and raised its quarterly dividend to $0.50.
The transplant diagnostics company reported GAAP net income of $19 million for Q3 and said its AlloHeme test remains on track for a planned launch in the first quarter of 2027.
Biohaven says the US regulator has treated its troriluzole resubmission as a complete response to the November 2025 action letter, with an advisory committee planned.
The rare disease company's October corporate deck sets out 2026 revenue and cost guidance, reports $2.1bn in cash and names Phase 3 votoplam in Huntington's disease as a priority.
Stoke says its FDA meeting covered analysis of a cognition and behaviour secondary endpoint in the Phase 3 EMPEROR study, with topline data due in Q3 2027.
The company also bought Fabry gene therapy ST-920 for $111m upfront, while the FDA meeting on votoplam in Huntington's disease has slipped to the first quarter of 2027.
Gilead reports Q3 product sales of $8.3bn, driven by HIV growth, and lifts full-year guidance while noting a new FDA approval and wider voluntary licensing for lenacapavir.
The US drugmaker reported third-quarter revenue of $226.8 million, as the FDA recognised orphan exclusivity for ONAPGO and the Indivior merger approaches its expected 2 November close.
BridgeBio's third-quarter revenue was lifted by US Attruby sales and a Bayer milestone, while three priority-review FDA decisions and two EMA reviews approach.
The company reported higher third-quarter sales, held its 2026 revenue guidance and lowered its tax-rate outlook, with a March 2027 FDA action date set for zanzalintinib.
A software problem can stop the RotaFlow Console charging its battery after battery mode has been used, and the manufacturer treats all marketed devices as affected.
Health Canada lists a Type II recall of OptiCross catheters covering revised flushing guidance, reinforced air-management practices and forthcoming Instructions For Use updates.
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.