Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
The US biotech posted $45.0m in third-quarter revenue, while FDA approved a label update for its ROS1+ lung cancer drug four months ahead of schedule.
Acadia Pharmaceuticals reported Q3 2026 revenue of $342 million and said DAYBUE (trofinetide) for Rett syndrome has launched in Germany after European Commission approval in August.
The company has released abstracts covering LOTIS-7, a marginal zone lymphoma trial and full Phase 3 LOTIS-5 results, including a progression-free survival gain and higher Grade 5 event rates.
The US plasma company reported 31% year-on-year ASCENIV sales growth and kept its full-year revenue guidance, while the FDA responded positively to its pre-IND package for a pneumococcal candidate.
The aesthetics company posted an adjusted EBITDA profit despite a GAAP operating loss, and expects FDA approval of Evolysse Sculpt by the end of the year.
The precision oncology company says Phase 3 breast cancer enrollment should finish in mid-2027, with updated vascular anomaly data due at ASH on 14 December.
Arcutis raised its full-year sales outlook to $535–545 million, and the FDA has set a February 2027 action date for Zoryve cream in infants with atopic dermatitis.
Patient-reported results from pivotal Study 302 suggest responders had sustained quality-of-life gains, though the analyses were descriptive and fall outside the FDA-approved prescribing information.
Patient-reported results in relapsed or refractory cutaneous T-cell lymphoma point to sustained improvements among responders, though the analyses were descriptive and sit outside the US label.
The US launch of daraxonrasib in previously treated metastatic pancreatic adenocarcinoma brought in $197.6m in roughly five weeks, while a European Commission decision is still pending.
Olympus devices loaned to customers were wrongly used for animal purposes, reprocessed and then sent to hospitals for human use, prompting a Type II recall with sterility concerns.
A Type II recall covers one lot of Plateletworks Collagen Kit after internal testing found many tubes aggregated poorly, risking false suggestions of abnormal platelet function.
Translational data at SITC 2026 show immune-activation rises in most evaluable patients, with HPV-16-specific T-cell expansion in six of 14 and tumour shrinkage in four of those six.
Kayserbetten has assessed that IDA beds sold in Canada carry an injury risk comparable to a serious incident abroad, tied to hand control locking instructions.
UroGen reported a 35% quarter-on-quarter rise in ZUSDURI net revenue, a narrower loss, and a June 2027 FDA goal date for UGN-103 in low-grade bladder cancer.
The clinical-stage immune disease biotech says the share consolidation, aimed at regaining Nasdaq bid-price compliance, will cut shares outstanding from about 33.3 million to about 1.11 million.
The US gene therapy developer also licensed OCU400 for the Middle East and North Africa and reported $84.6 million in cash alongside its third-quarter results.
The company kept its 2026 WAKIX revenue guidance at $1.00B-$1.04B and reported favourable 14-day Phase 1 multiple-ascending-dose data for its orexin-2 agonist BP-205.
Neuronetics narrowed its third-quarter net loss to $1.6M, holding full-year revenue guidance while an FDA 510(k) for an accelerated NeuroStar protocol is under review.
The US biotech filed its NDA in October 2026 and says a Phase 3 confirmatory trial will start in Q2 2027, while cash runway extends only to mid-Q1 2027.
The Bahamian regulator has granted provisional approval and priority designation to the retinitis pigmentosa gene therapy, as Ocugen reports full Phase 3 enrolment and a BLA target of 2Q 2027.
The royalty investor reported third-quarter Portfolio Receipts of $890m, lifted its full-year outlook and bought royalties on two newly commercial dermatology and rare-disease products for $100m each.
The US maker of the NeuroStar TMS system cites revenue and patient figures in an investor presentation that also flags going-concern and credit facility risks.
The preclinical contract research group reported Q3 revenue of $982.7 million, down 2.2% as reported after divestitures, and raised its full-year revenue and non-GAAP earnings outlook.
The wholesaler's full-year sales rose 5.0%, helped by the OneOncology acquisition, while it guides fiscal 2027 adjusted diluted EPS to $19.40-$19.75.
The US healthcare group lifted full-year profit and cash-flow forecasts, citing stronger performance in its insurance and pharmacy divisions, and flagged expanded GLP-1 weight management offerings.
The orthopaedic device maker reported hip and technology-segment growth, a drop in knees, and raised its 2026 organic growth and adjusted earnings guidance.
The US medical supplies group reported third-quarter net income of $318 million, helped by tariff refunds, and lifted its full-year organic sales growth guidance while holding its EBITDA outlook.
The company submitted its US biologics licence application on 30 September and expects an FDA acceptance decision by end-November, with a PDUFA date by mid-December.
The agency has accepted uniQure's accelerated-approval application for ifezuntirgene inilparvovec, while the UK MHRA has validated a marketing authorisation application for the same product.
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.