Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
The Danish Medicines Agency reports delivery difficulties with NorLevo 1.5 mg tablets from Paranova Danmark ApS, with no end date given.
The District of Delaware has created a task force pooling federal and state agencies to pursue fraud against federal government programmes, according to a notice listed by HHS OIG.
Attorney General Josh Kaul says state prosecutors have filed criminal charges over more than $1 million in allegedly fraudulent claims submitted to Wisconsin's Medicaid programme.
The New Jersey-based laboratory group has paid $13,014,576 plus interest over claims that exclusive entertainment perks were used to induce referrals paid for by federal healthcare programmes.
Lab Genomics LLC and its owner, Leena Dalal, have agreed to pay the US government $1.25m over alleged illegal payments to marketers, according to HHS OIG.
A federal grand jury in the Southern District of Florida has charged Dr Edgard Salazar with conspiring to bill Medicare for consultations that never took place and unwanted braces.
The Dutch inspectorate has published a manufacturer field safety notice after reports of soft connectors coming off Intersurgical's sterile and non-sterile breathing systems.
FDA analysis found the male sexual enhancement product, sold online and via eBay since at least October 2021, contains undeclared sildenafil and acetaminophen; no adverse events have been reported.
Terumo BCT has notified customers using Spectra Optia apheresis systems on software 12.1, with Health Canada noting a possible treatment delay if the AIM system cannot be disabled.
At the 2026 AGM, Mesoblast's chair described a shift from research-led business to commercial focus, citing roughly US$115 million in fiscal 2026 net sales of Ryoncil.
Mesoblast says FY2026 net revenue reached US$115M in the first full year of US sales of Ryoncil, while its pipeline and label-expansion studies progressed.
Dr Gregory George will act as interim chief operating officer while Mesoblast aligns with the FDA on a BLA in LVAD patients and awaits Phase 3 back pain data.
TMC the metals company reports about $123 million in liquidity and a later NOAA timeline for its USA-A application, after the agency said it must review more than 1,600 public comments.
The US biotech says median progression-free survival has not been reached with 30 mg onvansertib plus FOLFIRI/bev in first-line RAS-mutated metastatic colorectal cancer, and it is preparing a registrational trial.
The company formerly known as FSD Pharma reports a smaller loss for the nine months to September 2026, with cash near $3.6M and digital assets near $8.7M.
The Nasdaq-listed former biopharma company, now selling fire safety products in Malaysia, also reports an effective S-4 for its proposed Future NRG combination.
The OTCQB-listed niche generics maker reported higher revenue and operating income for the quarter to 30 September 2026, with net income of $17.3m attributable to common shareholders.
The US gene-editing company also launched a partner-funded Indian Mustard programme and cut nine-month operating cash use by about 19%, to $30.2 million.
Obsidian Therapeutics reported Q3 2026 results alongside updated SITC data on its engineered TIL therapy, and said enrolment in the Agni-01 registration-enabling cohort should complete by end of Q1 2027.
The capsule endoscopy maker reported a $7.3M quarterly net loss, completed enrolment in its CapsoCam Colon study and raised about $17.8M net in September.
The company has sent the FDA a briefing document seeking agreement that the nafamostat study can close at the end of 2026 even if fewer than 70 patients are enrolled.
Fractyl Health says its duodenal ablation device hit the co-primary endpoint in weight maintenance after GLP-1 discontinuation, while it restructures and drops Rejuva gene therapy.
The blood purification company reports $9.7M quarterly revenue and a narrower operating loss, while it pursues FDA marketing authorization for DrugSorb-ATR and tries to rebuild German sales.
The ultrafiltration specialist reported flat third-quarter sales of $2.2 million, a higher gross margin and a 24% smaller operating loss, alongside a pediatric filing and two distribution deals.
The dermatology company's U.S. YCANTH revenue rose 57.9% year over year, while enrolment in the first of two pivotal common warts trials is finished.
The RNS System maker cut its full-year revenue outlook to $91–92 million while advancing Remote Care, an idiopathic generalised epilepsy amendment and a new adolescent study.
In its third-quarter MD&A, the company reported a deferred-interest loan extension to licensee Unbuzzd, a cancelled warrant, a larger equity stake and a Nasdaq-only listing.
The US company says enrolment in its Phase 3 rilparencel trial will exceed 500 patients, while cash of $141.9 million funds operations into mid-2027.
The FDA has accepted Intellia's BLA for the one-time in vivo gene-editing therapy lonvoguran ziclumeran, with a PDUFA date of 10 March 2027 and no advisory committee currently planned.
Nektar reported Q3 2026 revenue of $9.4M, a $55.7M net loss and $952.9M in cash as its late-stage rezpegaldesleukin programme moved into full recruitment mode.
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.