Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
The hybrid pharma-device company's presentation highlights January 2026 FDA approval for re-administration of iDose TR, new Phase 3 non-inferiority analysis and earlier-stage iDose follow-on products.
Anika Therapeutics reported third-quarter revenue of $30.6 million and raised parts of its 2026 guidance, but the FDA told it in October that its Hyalofast cartilage-repair application cannot be approved.
The company reported third-quarter revenue of $1.3 billion and net income of $162 million, and highlighted US approval of mFLUSIVA alongside mixed pipeline news.
AIFA's monitoring report puts public drug expenditure at 19.26% of the national health fund for the first four months of 2026, based on a provisional fund value.
The Office of Health Advancement guidance agenda covers combination products, emergency use authorisation, informed consent, paediatric research and orphan designation, with public comment invited.
A direct final rule clarifies that nonclinical tests can include cell-based assays, organs-on-chips and computer models, without mandating any method or changing evidentiary standards.
Germany's regulator has posted a manufacturer notice from Life Technologies Holdings concerning software for the Ion Torrent Genexus Dx, but the public listing gives no detail of the problem.
Germany's regulator has posted a manufacturer notice for the V8 UltraCE, but its public description gives no detail on the problem, affected lots or required actions.
Germany's regulator has listed an urgent field safety notice from Intuitive Surgical covering a surgical scissors tip, but details of the issue sit only in the manufacturer's attached advisory.
Germany's BfArM has listed an Urgent Field Safety Notice from exocad GmbH covering exoplan, with the substance contained in the manufacturer's attached Advisory Notice.
Ravimiamet says Sanofi Winthrop Industrie is ending production and sale of the furosemide prolonged-release capsules globally, with no new deliveries to Estonia and pharmacy stocks running low.
The Danish Medicines Agency says quality problems have disrupted supply of Centyl med Kaliumklorid 2.5+573 mg coated tablets, with no end date given.
The Danish Medicines Agency has listed bendroflumethiazide/potassium chloride 2.5+573 mg tablets as in supply failure, opening the way for equivalent foreign-labelled products under section 29(2) of the Medicines Act.
The Czech authority says selected lots of the two condom brands are being pulled from the market as a precaution, and advises consumers not to use them.
Italy's medicines agency has activated the web registry and published clinical forms for vorasidenib, with reimbursed use under the national health service possible from 6 November 2026.
Italy's medicines agency has revised the amivantamab registries for two lung cancer indications, adding subcutaneous schedules and their marketing authorisation numbers from 6 November 2026.
Italy's medicines agency has updated the durvalumab registry for resectable non-small cell lung cancer, adding a further platinum-based combination to the neoadjuvant phase in two registry forms.
Italy's medicines agency has revised the registries for Enhertu in breast and gastric cancer, removing a block on treating patients with active, symptomatic or uncontrolled brain metastases.
Italy's medicines agency has revised the monitoring registry for amivantamab in advanced EGFR exon 20 insertion lung cancer, adjusting when carboplatin-containing combinations are selected on the request form.
Italy's medicines agency has revised the registries for tislelizumab in gastric/GEJ adenocarcinoma and oesophageal squamous cell carcinoma, effective 6 November 2026, following Determination PRES/1512/2026.
Italy's medicines agency has revised the Lunsumio registry for relapsed or refractory follicular lymphoma, with changes effective 6 November 2026 following Determination PRES/1504/2026.
The regulator's new standard covers products whose global marketing authorisations began between 2014 and 2021, with an explanatory note and a downloadable CSV file.
Italy's medicines agency has activated the web registry and published clinical forms for vorasidenib, with reimbursed use for grade 2 IDH-mutant astrocytoma or oligodendroglioma starting 6 November 2026.
Italy's medicines agency has revised the registries for trastuzumab deruxtecan in breast and gastric cancer, removing a treatment block for patients with active, symptomatic or uncontrolled brain metastases.
Italy's medicines agency has changed the timing of selecting carboplatin-containing combination regimens in the Rybrevant (amivantamab) monitoring registry's drug request form for first-line NSCLC.
Italy's medicines agency has revised the Tevimbra (tislelizumab) registries for two first-line oesophageal and gastric cancer indications, effective 6 November 2026.
The Italian medicines agency has amended the Lunsumio (mosunetuzumab) registry from 6 November 2026, adding the new subcutaneous posology to the request form and new AIC codes to the dispensing form.
The EMA committee's November meeting also produced five further positive opinions on new products, several variations, and an extension of two avian influenza vaccine authorisations.
Austria's BASG says the revised Q&A allows higher acceptable intakes under a less-than-lifetime approach, extends CAPA timelines to seven years and adds a polymer-bag risk factor.
IGJ has released an inspection report on Crinetics Pharmaceuticals Europe GmbH in Amsterdam, but the available material does not disclose findings, required measures or the type of inspection.
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.