Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
Germany's medicines and devices regulator has posted an urgent field safety notice from Beaver-Visitec International covering two ophthalmic surgical blade products, with details held in a manufacturer PDF.
The German regulator has listed an urgent field safety notice from RAL Diagnostics for two laboratory staining instruments; details sit in the manufacturer's Advisory Notice.
The Danish Medicines Agency has posted a supply notice saying Teva Denmark A/S has stopped marketing Orlistat "Teva" 120 mg hard capsules for commercial reasons.
DKMA says supply of Boehringer Ingelheim's romifidine veterinary injection is disrupted, with the disruption expected to last from early to mid-November 2026.
The UK regulator's weekly roundup names manufacturers including Abbott, Philips, Abiomed and Beckman Coulter, but gives no detail on the nature of the problems.
The UK regulator has released decisions on adverts reported as breaching medicines advertising law, with documents covering weight-loss services and websites offering medicinal treatment services.
ŠÚKL has released a Direct Healthcare Professional Communication on Respreeza, citing possible compromised injection vial integrity that could lead to a missed dose or potential infection.
Denmark's medicines agency says supply of Paracox-8 Vet. oral suspension is disrupted, with increased sales and demand given as the cause.
The Danish Medicines Agency says GlaxoSmithKline's meningococcal B vaccine faced shortages from April to mid-June 2026, with increased sales and demand cited as the cause.
The Danish Medicines Agency expects Inlyta 7 mg film-coated tablets from Pfizer ApS to be constrained from early November to early December 2026, citing increased demand.
Ravimiamet (Estonian State Agency of Medicines) published an overview of human medicines marketing authorisations newly granted and renewed/updated in late October and early November 2026. It is a routine administrative listing useful for tracking the Estonian national market status of products, with no specific safety action indicated.
Ravimiamet (the Estonian Medicines Agency) published an overview of newly registered and updated marketing authorisations for human medicines. The title refers to July 2026, but the description refers to late October and early November 2026, so the period covered is unclear. It is a routine administrative listing that is useful for tracking national authorisation status, and the input names no specific products or safety actions.
A Dutch inspectorate notice says Getinge's D.03 software slows the compressor during autofill, potentially lowering vacuum and triggering an alarm that prevents Cardiosave pumps from starting or resuming therapy.
Compact Medical is removing nine ButterflyBVM lots and applying a pre-use test correction to 22 others after holes were found forming in the bellows.
The Nasdaq-listed calibration and test-measurement firm raised its full-year service growth outlook and flagged an August acquisition that extends its hospital biomedical reach.
With cash of $1.0m covering operations only into mid-November, InMed says its proposed Mentari Therapeutics merger should cure a Nasdaq equity shortfall; shareholders vote on 4 November.
The specialty ingredients maker reported Adjusted EBITDA of $121 million for the quarter to 30 September 2026 and issued fiscal 2027 guidance, despite a GAAP net loss.
The EEG-based point-of-care company reported a 90% gross margin, launched its delirium monitoring solution in full and won two FDA 510(k) clearances.
The US drugmaker reaffirmed its 2026 guidance and reported $285M in cash and investments, with Phase 3 ACCEL data for tenapanor in chronic idiopathic constipation due in the second half of 2027.
Profound Medical has agreed to supply TULSA-PRO to Cook Medical's iMRI Division for US sales through the Copernicus program, while keeping its own direct sales team.
Growth in Repatha, Evenity, Uplizna, Imdelltra and Tezspire offset sharp declines in Prolia and Xgeva, while Amgen says it continues to engage the FDA on Tavneos.
After FDA approvals for GENGLYCOS and FAYUVI, Ultragenyx is restructuring, ending two programmes and reaffirming a target of profitability in 2027.
The US company also seeks EU re-examination of arimoclomol and plans a paediatric sNDA for infants under 24 months in the first quarter of 2027.
Corcept Therapeutics reports third-quarter net income of $126.8m and flags a CHMP positive opinion for relacorilant in ovarian cancer and a December US decision date in Cushing's syndrome.
The cardiac surgery device maker reported net income of $4.1 million for the quarter and issued full-year 2026 revenue guidance of about $606–610 million.
The US rare-disease drugmaker reported Q3 net product sales of $185.7 million and flagged several regulatory submissions planned for the first half of 2027.
Denali's Hunter syndrome therapy Avlayah, approved in March, has gained commercial coverage for over 70% of US lives, and a permanent J-code took effect on 1 October.
The company has refiled its epinephrine prodrug sublingual film application with the FDA following January's Complete Response Letter, and plans a Health Canada submission in the fourth quarter.
Certain lots of Fresenius Kabi Canada's anticoagulant sodium citrate 4g/100mL have manufacturing-related leak defects; Health Canada advises bag-by-bag checks rather than withdrawal.
Alkermes reported higher third-quarter 2026 revenue on LUMRYZ sales after the Avadel transaction, while GAAP net income was $16.3 million, and it left its 2026 financial expectations unchanged.
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.