Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
Hungary's public health institute says 4,500 Vaxigrip and 2,000 Fluenz doses for 2026/2027 are now available through GPs and paediatricians for eligible young children.
The Danish Medicines Agency lists quality problems as the reason for disrupted supply of Elanco's veterinary Galliprant 100 mg tablets, expected to last until mid-February 2027.
A typographical error on the front of the carton misstates the hydrochlorothiazide strength as "12. mg"; the MHRA says the tablets are unaffected and supply should continue.
The agency's draft guidance sets out recommendations for first-in-human and limited-experience oncology protocols, and excludes haematologic malignancies; comments are open until 11 January 2027.
Germany's regulator has posted an urgent field safety notice from Urotech GmbH on its Renodrain Nephrostomie device, but the public listing gives no details of the problem.
The Icelandic biosimilar maker reports $323.4M adjusted revenue to September, keeps its full-year guidance, but now expects to land towards the lower end of the range.
HappyScale Wellness Corp., trading as Join Luma, says a seven-provider comparison ranked it cheapest for compounded tirzepatide, while noting the product is not FDA-approved.
A new EMA web page outlines expected outcomes of AI use across the EU network and compiles a timeline of milestones from 2021 to August 2026.
The Slovak medicines agency has cancelled the original dates for submitting data to match EUDAMED with its national medical device database, with further steps set out in a separate document.
Germany's medicines and devices authority has posted a manufacturer field safety notice for various AMOR Gummiwaren condom models, with details held only in the attached advisory.
German regulator lists a notice from BD Switzerland Sarl on BD Connecta, but defect, affected lots and required actions appear only in the manufacturer's attached advisory.
The UK regulator has authorised Incyte's retifanlimab (ZYNYZ) with carboplatin and paclitaxel for adults with inoperable, metastatic or recurrent anal canal cancer, via the International Recognition Procedure.
The Health and Youth Care Inspectorate has released a supervisory report on Waymade BV, but the material available gives no findings, deficiencies or required corrective measures.
The EU framework brings existing animal, public and occupational health measures into one reference document, as bird flu detections in wild birds reach a record level.
The agency's refreshed page sets out who must register devices before market placement, with EUDAMED now replacing MHRA registration for most Northern Ireland devices.
DG SANTE and the EMA have agreed with Singapore's Health Sciences Authority to exchange information on medicines and medical devices, with immediate effect.
Ravimiamet says the new influenza vaccine batch is split between pre-booked institutions and the open market, and warns that November supplies will not cover everyone who wants a jab.
The Danish Medicines Agency reports production problems affecting SomaKit TOC 40 microgram, with disruption expected from the start to the end of November 2026.
Germany's regulator has posted a manufacturer advisory on the Vanta INS, but the published listing does not describe the issue or the actions required.
Germany's regulator has listed a manufacturer safety notice for the deep brain stimulation programming software, but the public entry gives no detail on the issue or required actions.
Germany's medicines and devices regulator has listed a manufacturer notice for the Shockwave Reducer, but the nature of the problem is only in the attached Advisory Notice.
Germany's medicines and devices authority has posted an Urgent Field Safety Notice from Bolton Medical covering three aortic stent-graft products, with the manufacturer's Advisory Notice attached.
Too little bonding solvent in manufacture may let soft connectors separate from the tubing, risking loss of ventilation; Intersurgical has told US customers to stop using and quarantine 12 affected product codes.
Teleflex subsidiary Arrow International has told customers to quarantine guidewires and PICC or JACC catheters whose hydrophilic coating may detach and release particles into the bloodstream.
The Hungarian drugmaker reports reported pharma revenue up 2.6% to HUF 686.5bn despite a roughly 9-point currency drag, and raises its full-year outlook.
The Danish drugmaker now expects 11-12% revenue growth and 15-19% adjusted EBITDA growth at constant exchange rates, citing strong US Vyepti sales and stronger Partner Markets.
Roche will bring 16 abstracts to the CTAD Congress in Boston, spanning its brain-shuttle antibody, an oral NLRP3 inhibitor and its Elecsys blood-based Alzheimer's tests.
The company reached its 120-patient target in the placebo-controlled RESOLVE study and reported Q3 2026 results, with cash it says lasts into the second half of 2028.
Legend Biotech posted third-quarter CARVYKTI net trade sales of about $710 million and operating income of $46.8 million, and said the FDA cleared its IND for CD19/CD20 in vivo CAR-T LB2501.
Alcon reports 10% higher third-quarter net income, while a $505m charge for discontinuing PowerVision intraocular lens programmes drives a 35% fall in nine-month operating income.
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.