Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
Auvelity, Sunosi and Symbravo together generated $259.7m in the quarter, while the company narrowed its net loss to $12.9m and began a Phase 3 trial of AXS-05 in smoking cessation.
The agency has accepted the accelerated approval application for AMT-130 and tentatively plans an advisory committee discussion, with a decision due by 1 May 2027.
Portugal's medicines authority is taking part in the international campaign running 2–8 November 2026 under a slogan telling people not to ignore suspected adverse drug reactions.
BfArM has published a manufacturer field safety notice for the Atellica CH APO B assay, but the issue, affected lots and user actions appear only in an attached advisory.
CBER's recommendations describe how blood establishments may reevaluate donors who are initially reactive for hepatitis B surface antigen, provided other suitability requirements are met.
The regulator refreshed its published list of products with a Traditional Herbal Registration on 2 November 2026, but the page does not say which products changed.
HHS OIG reports the sentence over the dispensing of more than 300,000 oxycodone 30mg pills to patrons with no medical need for the drug.
Violetta Mailyan was sentenced for billing Medicare more than $45 million for Botox injection services that were medically unnecessary and never provided, HHS OIG reports.
A guilty plea in a $227 million scheme centres on stolen beneficiary data used to bill Medicare for COVID-19 test kits that were never provided, according to HHS OIG.
CBER's final guidance sets out a science- and risk-based approach to potency assurance for CGT products and supersedes the January 2011 potency tests guidance.
CBER's final guidance sets out a risk-based Potency Assurance Strategy for CGT products, covering development through post-market verification and superseding the agency's 2011 potency testing guidance.
JAZMP has published a DHPC urging careful visual inspection of Caelyx 2 mg/ml vials after some batches were found with incorrectly crimped aluminium seals.
Germany's medicines and devices authority has listed an urgent field safety notice from Medtronic Inc for its MyPTM App, a medical app; details sit in the manufacturer's Advisory Notice.
The Danish Medicines Agency lists Orifarm's Cellcristin 1 mg/ml solution for injection as affected by delivery difficulties, with disruption expected to run until the end of March 2027.
The Danish Medicines Agency lists the end of Victoza (liraglutide) 6 mg/ml pre-filled pen marketing as a permanent cessation for commercial reasons.
Italy's medicines agency says risk-sharing procedures are no longer active for HOLOCLAR's registered indication, but treatments first dispensed before the cut-off stay under the existing arrangements.
Italy's medicines agency says monitoring of the HOLOCLAR registry stopped on 31 October for its authorised indication, with treatment of current patients continuing under existing registry rules.
Italy's medicines agency has activated the web registry and published monitoring forms for mepolizumab in uncontrolled eosinophilic COPD, following a determination announced in the Official Gazette.
The Danish Medicines Agency has flagged upcoming supply problems for Pfizer's sulfasalazine gastro-resistant tablets, attributing them to increased sales and demand.
Denmark's medicines agency says Valneva Sweden AB's IXCHIQ will face supply difficulties for about two years, citing commercial reasons.
The Danish Medicines Agency says production problems at Krka Sverige AB are disrupting supply of Nimvastid 1.5 mg hard capsules, with disruption expected from late April to mid-December 2026.
The Slovak medicines authority is backing the 2–8 November global campaign with the message not to ignore side effects, and has restated how suspected reactions can be reported.
The Czech regulator is backing the Uppsala Monitoring Centre campaign, running 2–8 November, which encourages patients and health professionals to report suspected adverse drug reactions.
The agency has widened its 2026 essay competition to pharmacy students and is urging Yellow Card reports on medicines and devices, with low reporting rates for AI-enabled devices flagged.
The UK regulator updated its published list of herbal medicines with a traditional herbal registration on 2 November 2026, with the document now a 33-page PDF.
The Dutch health inspectorate has published a manufacturer field safety notice on a heating element time-out error affecting bioMérieux EMAG systems already running the SP4 Patch version 2.
IGJ has published a Philips field safety notice on a roughly 2mm display offset affecting pulsed wave sample volume gates with the C5-1 transducer and Abd Vasc preset.
A Field Safety Notice published by Dutch inspectorate IGJ says deposits on the Sample Arm B probe of Sysmex CN Series analyzers may produce falsely low measurements.
The Dutch inspectorate has published a manufacturer field safety notice dated 5 October 2026 on incompatible lead and percutaneous extension pairings in Medtronic's InterStim SureScan MRI system.
Medtronic has issued a field safety notice for the Abre self-expanding venous stent system, adding an approved manual-expansion workaround for the rare event of partial stent placement.
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.