Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
The protein degrader developer reported Q3 2026 results, with ARV-6723 in a Phase 1/2 solid tumour trial and EU and UK filings planned for ARV-102 in PSP.
Revvity reported Q3 revenue of $729 million, with Life Sciences outpacing Diagnostics, and raised its full-year pro forma outlook while a China immunodiagnostics sale remains pending.
CBER has determined that the QUELIMMUNE Pediatric SAVE Surveillance Registry fulfils the post-approval study requirements attached to the device's Humanitarian Device Exemption approval, SeaStar Medical said.
The company also closed its Phase 3 OptimUM-010 trial in primary uveal melanoma over enrolment problems, as it reported Q3 2026 results and a $1.15 billion cash position.
The gene-editing company's third-quarter update points to a potential US filing in sickle cell disease and completed BEAM-302 pivotal dosing in H1 2027.
The US regulator has granted Fast Track status to PIKTOR plus paclitaxel in biomarker-selected endometrial cancer, with Phase 2 PIK-201 topline data expected by the end of 2026.
The US generics and specialty drugmaker swung to a GAAP net loss on Kashiv-related costs, while lifting revenue, adjusted EBITDA and adjusted EPS targets but trimming its cash flow outlook.
Rhythm Pharmaceuticals reports 29% quarterly growth for IMCIVREE after its US hypothalamic obesity launch, alongside a cheaper bivamelagon licence deal and a new term loan.
Pfizer reported Q3 revenues of $16.6 billion and lifted full-year revenue and adjusted EPS guidance, while booking a $650 million charge for its Innovent Biologics in-licensing deal.
The gene-editing company reports $108 million in cash, expected to last through 2028, alongside a first dosing in its DMD study and a late-breaking HBV presentation.
Teva's generic lenalidomide sales fell in the US, but AUSTEDO, AJOVY and UZEDY grew a combined 33% and all three received raised 2026 outlooks.
The Florida cellular medicine manufacturer says it has received AABB's new certification, which assesses quality management only and does not evaluate its cellular products.
Rhythm Pharmaceuticals' Q3 2026 update reports a Japanese launch on 13 October, US uptake after March approval, Phase 3 plans for bivamelagon and European reimbursement filings.
The company says it will finish its FDA submission shortly and plans a first-half 2027 launch if approved, backed by a priority voucher and $444.0 million in cash.
Karyopharm Therapeutics and affiliate KPT Texas LLC have begun soliciting votes on a prepackaged Chapter 11 plan, with every voting creditor class signed up to a restructuring support agreement.
A software issue on DxC 500 AU Clinical Chemistry Analyzers may reset custom test units to system defaults without telling users, according to a field safety notice published by the Dutch inspectorate IGJ.
Complaint investigations confirmed the reagent lot exceeds the within-lab imprecision limit of 7.0% CV on Atellica CH and CI analysers, according to a Dutch inspectorate listing.
The Dutch inspectorate has published a manufacturer warning on a Medartis scaphoid plate whose locking contours ended up on the convex underside after being bent in the wrong direction.
Italy's medicines agency found no medicine qualifying for innovative status in the October 2026 review, but released reports on Ezmekly and Pedmarqsi, which both had negative outcomes.
Denmark's medicines agency reports delivery difficulties for Sandoz's clozapine 100 mg tablets, expected to last from October 2026 to the end of January 2027.
The Danish Medicines Agency says increased demand has disrupted supply of Frivelle 1.5 mg tablets from Orifarm Generics, with the notice updated on 3 November 2026.
The European Commission says it and Canada are intensifying joint work on medical countermeasures for health-emergency preparedness and response, though the announcement sets out no detailed measures.
DG SANTE has published MDCG 2026-6 on clinical evidence for orphan in vitro diagnostics, though the accompanying description refers to a different IVD classification guidance.
The pre-submission advice procedure for sponsors using CTIS, run since 2024 as a pilot, will continue beyond 2026 with updated guidance and templates.
BASG and AGES join the 11th international campaign urging reporting of suspected side effects, citing 14,528 Austrian pharmacovigilance reports in 2025 and a changed counting method.
The agency has issued Appendix V of the QRD documentation, covering the standard statement and contact details for reporting suspected adverse reactions; the changes are not specified.
France's regulator reviewed 29 manufacturers and distributors of professional aesthetic laser and pulsed-light equipment and found that only one had completed MDR certification by summer 2025.
Ravimiamet's October overview lists transfers of Diclofex-type spray DICLOFLEX to Giuliani and of MIGARD tablets to Phoenix Labs Unlimited Company.
Ravimiamet says a falsified version of the dental cream, sold via Poland's Allegro platform, may have reached Estonia and could contain agents not meant for use in the mouth.
Estonia's medicines agency has published its monthly overview of safety-related product information updates, covering antimalarials, cancer therapies, an antibiotic, hormonal IUDs, a topical scabicide and growth hormone.
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.