Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
The Dutch inspectorate IGJ has published a manufacturer field safety notice saying certain Carestation 850 and 850c units may release less anaesthetic vapour than the user selects.
IGJ reports three cases of head tube welds cracking and detaching on the Medema A/S Mini Crosser X-model 3W, with replaced parts in repairs also possibly at risk.
Germany's medicines and devices regulator has listed an urgent field safety notice from EPflex Feinwerktechnik GmbH covering various guidewires, with details held in the manufacturer's advisory notice.
The US regulator is requiring application holders for every GLP-1 RA to add a Warnings and Precautions entry on a potential increased risk of the rare optic nerve condition NAION.
The US regulator has upgraded the Abiomed action to its most serious category, citing quality issues in heart pump controllers that could delay therapy or cause loss of haemodynamic support.
FDA CBER says postmarketing reports include tumours with vector integration near the GLI1 oncogene, and it is weighing regulatory action on Zolgensma and Itvisma.
EOF has ordered the recall of every non-expired lot of the medical device 'Steriflush Syringes NaCl 0.9%', with affected lots listed in a table attached to the decision.
The Israeli plasma-derived therapeutics company cites U.S. KEDRAB sales as the main driver of $152.2 million in nine-month revenue and now expects 2026 revenue of $205-208 million.
Week 24 data from the head-to-head psoriatic arthritis study show 54.9% of bimekizumab-bkzx patients reaching ACR50 versus 43.8% on risankizumab, with no new safety signals.
Post-hoc analyses of the Phase 3 PHOENYCS GO study, shown at ACR Convergence 2026, favour the investigational drug over placebo, but the measure is unvalidated and the analyses fall outside any regulatory filing.
Jiade Limited's unaudited half-year accounts show revenue slipping to RMB 8.3m while general and administrative spending climbed to RMB 48.8m, including about RMB 33m of share-based pay.
Kamada's unaudited interim accounts to 30 September 2026 show higher revenue and profit year on year, lower R&D spending and $24.2M in declared dividends.
The Israeli biotech's Yavne CDMO operations and an expanded U.S. customer deal drove sales growth, but a one-off accounting gain masks a wider operating loss.
The US maker of pharmaceuticals, cosmetic ingredients and medical lubricants reported Q3 2026 net income of $930,912, with Renacidin the main driver of pharmaceutical growth.
Can-Fite says a patient with advanced hepatocellular carcinoma who had a complete response in its Phase II Namodenoson study has reached ten-year survival, though the company stresses the case is anecdotal.
The randomised trial in late-line MSS colorectal cancer without liver metastases is intended to select the dose for a Phase 3 programme, with first results due in the first half of 2027.
Efgartigimod met its primary endpoint in a combined myositis population, but statistical significance was seen in IMNM and not in dermatomyositis alone, shaping argenx's filing plans.
A four-year exclusive deal with minimum purchase commitments covers Israel, with revenue expected from 2027 and talks on HMO reimbursement to follow.
The Eversense 365 maker reported Q3 revenue of $19.6M, driven by US growth, and raised its full-year outlook to $68-70M.
The US genetic testing company held its full-year revenue guidance at $475-490 million while lowering volume and revenue growth expectations for exome and genome testing.
The once-monthly antibody cut moderate-to-severe vasomotor symptom frequency by 83% versus 33% with placebo, and the company reported no serious or Grade 3+ adverse events in treated patients.
The portable MRI maker narrowed its quarterly loss to $6.0 million, kept 2026 revenue guidance and flagged an FDA submission for its Contrast PMR study by year-end.
The US sterilisation-assurance supplier issued its first fiscal 2027 guidance and said a September FDA inspection of its Montana biological indicator site closed without Form 483 observations.
The alpha-emitting radiopharmaceutical developer also reported EU orphan status for bamzireotide navoxetan, about $202 million in cash and a Q3 net loss of $32.4 million.
ArriVent BioPharma says firmonertinib did not meet progression-free survival goals in NSCLC, while reporting a cash position of $393.2 million that it expects to last to mid-2028.
The filing rests on skin frataxin as a possible novel surrogate endpoint, with the Phase 3 FORWARD-FA confirmatory trial still enrolling.
The company also won FDA Breakthrough Therapy status for the drug in major depressive disorder and plans an NDA filing in the first half of 2027.
Annexon's third-quarter update says its C1q inhibitor is under EMA review, a US BLA is due in Q4 2026, and ARCHER II's Month 15 primary endpoint is nearing assessment.
The US biotech reported Q3 2026 results, said Part 2c enrolment completes in November, and put its cash runway into the first half of 2028.
Trevi Therapeutics reported Q3 2026 results, citing a Phase 3 start in IPF chronic cough, a positive FDA meeting on non-IPF ILD cough and $299.4 million in cash.
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.