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sharinghttps://vigi-eye.com/analysis/2026-11-12-fda-draft-guidance-on-early-phase-solid-tumour-inds-comments-due-11-january-2027VigiEyeen2026-11-12FDA draft guidance on early-phase solid-tumour INDs: comments due 11 January 2027https://vigi-eye.com/analysis/2026-11-12-eu-bird-flu-framework-consolidates-existing-rules-but-market-access-impact-is-stVigiEyeen2026-11-12EU bird flu framework consolidates existing rules, but market access impact is still unclearhttps://vigi-eye.com/analysis/2026-11-12-urotech-s-renodrain-field-notice-what-to-do-when-a-bfarm-listing-says-nothingVigiEyeen2026-11-12Urotech's Renodrain field notice: what to do when a BfArM listing says nothinghttps://vigi-eye.com/analysis/2026-11-12-mhra-clears-retifanlimab-for-anal-cancer-via-international-recognition-procedureVigiEyeen2026-11-12MHRA clears retifanlimab for anal cancer via International Recognition 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Monitorhttps://vigi-eye.com/news/item/u/84bdb04361df9bd2VigiEyeen2026-11-13BfArM lists urgent field safety notice for EPflex guidewireshttps://vigi-eye.com/news/item/u/1b0486a64c689ee0VigiEyeen2026-11-13BfArM publishes QuidelOrtho field safety notice for VITROS A1c Slideshttps://vigi-eye.com/news/item/u/28d058b010f576ecVigiEyeen2026-11-13FTC sues to block Covetrus's $3.5bn acquisition of veterinary distributor MWIhttps://vigi-eye.com/news/item/u/f3c6105796019ee2VigiEyeen2026-11-13Denmark updates Voltabak eye drop supply notice, with shortage expected to run to mid-May 2027https://vigi-eye.com/news/item/u/94da0395c997918eVigiEyeen2026-11-13Florida man pleads guilty to $42M Medicare fraud over braces and cancer genetic testshttps://vigi-eye.com/news/item/u/a41129ce6d51dd12VigiEyeen2026-11-13Illinois Attorney General charges three people in two Medicaid fraud caseshttps://vigi-eye.com/news/item/u/4cb53039b9fc021fVigiEyeen2026-11-13Maryland Worker Pleads Guilty in D.C. 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detailshttps://vigi-eye.com/news/item/u/ad1d1d7a1b5ea3b2VigiEyeen2026-11-13AEMPS device bulletin flags seven safety notices and two new MDCG documents for Q3 2026https://vigi-eye.com/news/item/u/1ae9f332cea0a4fbVigiEyeen2026-11-13Catequentinib sarcoma application withdrawn in EU after negative CHMP opinion and re-examination requesthttps://vigi-eye.com/news/item/u/760fe9db3c3b36a3VigiEyeen2026-11-13CHMP backs Zybrivo (sintilimab) for first-line non-squamous NSCLC in combination with chemotherapyhttps://vigi-eye.com/news/item/u/e43108fef15b14dfVigiEyeen2026-11-13CHMP backs Krka's generic ruxolitinib for myelofibrosis, polycythaemia vera and graft-versus-host diseasehttps://vigi-eye.com/news/item/u/416f7c4634c689e0VigiEyeen2026-11-13CHMP backs Garzulys, a new insulin aspart biosimilar referencing NovoRapidhttps://vigi-eye.com/news/item/u/02359085cc0e9395VigiEyeen2026-11-13CHMP backs Evumed's generic fondaparinux sodium, referencing 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partnershttps://vigi-eye.com/news/item/u/01afa9ab8d4fb0ecVigiEyeen2026-11-13Wisconsin DOJ charges Milwaukee woman over alleged $1m Medicaid fraudhttps://vigi-eye.com/news/item/u/9f56adda26a20efcVigiEyeen2026-11-13Quest Diagnostics pays $13m to resolve Medicare and Medicaid kickback allegations over Giants suite ticketshttps://vigi-eye.com/news/item/u/4a4848d50adead77VigiEyeen2026-11-13California lab and owner pay $1.25m to settle False Claims Act kickback allegationshttps://vigi-eye.com/news/item/u/6eeae3b919fe5fb9VigiEyeen2026-11-13New York doctor indicted over alleged $6.8M Medicare fraud involving phantom consultations and orthotic braceshttps://vigi-eye.com/news/item/u/98d4be3a34d81393VigiEyeen2026-11-12Intersurgical breathing systems: connectors can detach from Smoothbore tube, IGJ posts safety noticehttps://vigi-eye.com/news/item/u/096b4d0ffe6919f6VigiEyeen2026-11-12Game Changer Products recalls all lots of 10 Day Forecast capsules over hidden 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UShttps://vigi-eye.com/news/item/c/1207ce0dc47e6dcf96acVigiEyeen2026-11-12Talphera asks FDA to let NEPHRO CRRT enrolment close early for nafamostat PMAhttps://vigi-eye.com/news/item/c/479e9cbd5cf0948a4ccbVigiEyeen2026-11-12Fractyl's Revita meets six-month REMAIN-1 endpoint as company plans De Novo filing and cuts 45% of staffhttps://vigi-eye.com/news/item/c/49b927bdf83963959ecfVigiEyeen2026-11-12CytoSorbents reaches operating cash flow breakeven in Q3 as revenue edges up 3%https://vigi-eye.com/news/item/c/ac71ce90ecaeb313ad2dVigiEyeen2026-11-12Nuwellis files 510(k) to extend Aquadex to children from 5 kg as losses narrowhttps://vigi-eye.com/news/item/c/83cfee75bd7ae5d4ca4bVigiEyeen2026-11-12Verrica reports record Q3 YCANTH sales of $5.7M as first common warts Phase 3 enrolment completeshttps://vigi-eye.com/news/item/c/14b30e205c84efcf0cabVigiEyeen2026-11-12NeuroPace slashes 2026 revenue guidance after weak third quarter, files Remote Care PMA 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INDhttps://vigi-eye.com/news/item/c/9fbcb5e48e5bf346317fVigiEyeen2026-11-12FDA clears InspireMD's CGuard Prime stent for transcarotid artery revascularisation via PMA supplementhttps://vigi-eye.com/news/item/c/1e1959b26c4f4d981030VigiEyeen2026-11-12BioCardia nears Japan filing for CardiAMP and plans Helix De Novo request in Q1 2027https://vigi-eye.com/news/item/c/40999777fb2a9dd43f37VigiEyeen2026-11-12Anaptys reports quarterly results as Jemperli sales rise 29% and GSK dispute ruling nearshttps://vigi-eye.com/news/item/c/2d24a6bfda6c83f2693dVigiEyeen2026-11-12InspireMD wins FDA approval of CGuard Prime for TCAR as Q3 loss narrowshttps://vigi-eye.com/news/item/n/aefa36d63542f0ec6dfbVigiEyeen2026-11-12Health Canada lists Type II recall of Beaver-Visitec Mini Blades over seal integrity concernhttps://vigi-eye.com/news/item/n/afd83dc6855e47380a10VigiEyeen2026-11-12Health Canada lists Type II recall of Siemens MAGNETOM Flow.Elite MRI software 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33 patientshttps://vigi-eye.com/news/item/c/a8a3a6d3a74391c1d321VigiEyeen2026-11-12Ascendis Q3 product revenue reaches €366M as CHMP backs TransCon CNP in achondroplasiahttps://vigi-eye.com/news/item/c/1153b0b25117a2151f04VigiEyeen2026-11-12ProQR cash rises to about €103.0M in Q3 2026 interim accountshttps://vigi-eye.com/news/item/c/1894d85ae7645b6e7c6eVigiEyeen2026-11-12Quantum BioPharma shareholders approve all meeting items; insider share placement closeshttps://vigi-eye.com/news/item/c/0d740df0c997bb47a30dVigiEyeen2026-11-12Auditor flags going-concern doubt at Marea and M2 despite $75.3M cashhttps://vigi-eye.com/news/item/c/bf93b6ac79ab74e38391VigiEyeen2026-11-12Marea and M2 Therapeutics post $52.2M half-year net loss as cash drops to $31.0Mhttps://vigi-eye.com/news/item/c/c1584475ccc063cf5fdaVigiEyeen2026-11-12MediWound Q3 revenue falls to $3.6M as EscharEx VALUE trial nears full enrolmenthttps://vigi-eye.com/news/item/c/c0395c1368c19f26603eVigiEyeen2026-11-12Alvotech nine-month 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faulthttps://vigi-eye.com/news/item/u/ecc21c3f54a5a44bVigiEyeen2026-11-12BVI flags seal integrity fault on some mini blade and lamellar blade surgical productshttps://vigi-eye.com/news/item/u/5e7f6fec6514c273VigiEyeen2026-11-12Remel Europe warns of underperforming Neisseria meningitidis Group C reagent lotshttps://vigi-eye.com/news/item/u/77e2c1941e1c9febVigiEyeen2026-11-12Dutch inspectorate publishes Boston Scientific field safety notice on Vercise Neural Navigator 5 softwarehttps://vigi-eye.com/news/item/u/a65298d96787f6e8VigiEyeen2026-11-12CMS extends nationwide freeze on new Medicare hospice and home health enrolmenthttps://vigi-eye.com/news/item/u/8a48f2ee15c4e7d7VigiEyeen2026-11-12BfArM lists urgent field safety notice for PTW Track-it softwarehttps://vigi-eye.com/news/item/u/93a2253666b48920VigiEyeen2026-11-12BfArM publishes field safety notice for Richter Rubber Technology condomshttps://vigi-eye.com/news/item/u/2f6bc92cbf08d4b9VigiEyeen2026-11-12BfArM publishes urgent field 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concernshttps://vigi-eye.com/news/item/u/20d9112c71e617c6VigiEyeen2026-11-12Slovakia's ŠÚKL issues guideline on notifying intent to vaccinate in pharmacieshttps://vigi-eye.com/news/item/u/99e5c729c83f122fVigiEyeen2026-11-12Hungary opens free flu vaccination for at-risk children aged 6–35 monthshttps://vigi-eye.com/news/item/u/0c93e9828bada761VigiEyeen2026-11-12Galliprant 100 mg tablets face Danish supply problems into February 2027https://vigi-eye.com/news/item/u/b7ca1c70880977a1VigiEyeen2026-11-12MHRA flags Class 4 packaging defect on Star Pharmaceuticals enalapril/hydrochlorothiazide tabletshttps://vigi-eye.com/news/item/n/a48a88967735d1da56c8VigiEyeen2026-11-12FDA Issues Draft Guidance on Early-Phase IND Protocols for Solid Tumour Trials