Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
Rigel Pharmaceuticals reported Q3 net income of $13.2 million and raised its full-year revenue guidance after the US launch of VEPPANU, the first FDA-approved PROTAC.
Higher Medicaid and 340B deductions and increased R&D spending cut profit, even as NERLYNX sales grew; Puma also began a Phase II lung cancer trial.
The organ-transplant technology company reported third-quarter revenue of $203.0 million and net income of $17.1 million, alongside FDA IDE approvals and a first European logistics tender win in Italy.
The cell and gene therapy logistics provider reported third-quarter revenue of $50.2 million, a net loss of $10.9 million and adjusted EBITDA of $1.1 million.
MannKind reported $45.0m in commercial product revenue, as the newly shipping Furoscix ReadyFlow and the paediatric Afrezza launch lifted sales, alongside early inhaled-pipeline data and a new licensing deal.
The company reported first sales of its IgA nephropathy therapy after July's accelerated approval and has asked the FDA to convert it to full approval, with an EMA filing planned for early 2027.
The US genetic testing company reported third-quarter revenue of $794M and a surge in clinical MRD oncology volumes, and raised its full-year revenue guidance.
ARS Pharmaceuticals posted $37.7M total third-quarter revenue, cut SG&A sharply and said interim Phase 2b data for ARS-2 in chronic spontaneous urticaria flares are due in Q1 2027.
The company has no product revenue yet, as gedatolisib shipments began only on 30 September, while payer coverage is reported at 91% of US commercial and Medicare lives.
The agency has accepted a Class 2 resubmission for the sublingual epinephrine film after a January 2026 Complete Response Letter, according to the company's November 2026 presentation.
The US diagnostics company lifted its full-year outlook to $1.36-1.37 billion as Oncology volumes grew and Shield screening tests rose to 83,000, alongside new FDA companion diagnostic approvals.
Protagonist Therapeutics says the FDA's August approval of rusfertide for polycythemia vera drove milestone income, while icotrokinra gained approvals in China, Japan and the EU.
The KIT inhibitor faces FDA action dates in GIST, non-advanced and advanced systemic mastocytosis, as Cogent reports $791.1 million in cash for Q3 2026.
Health Canada has published a Type II recall covering reusable monopolar and bipolar HF-cables from Olympus Winter & Ibe, with a reminder on service-life instructions.
The European Medicines Agency has released the outcome of a periodic safety update report single assessment for diethylamine-salicylate/escin, with the regulatory outcome listed as maintenance.
The cell therapy maker reported third-quarter net income of $14.2m, raised full-year revenue and adjusted EBITDA margin guidance, and said a possible 2027 UK launch of MACI remains on track.
The US vaccine developer reported $68 million in third-quarter revenue and a $31 million net loss, with cash of $627 million at the end of the period.
The US firm says the FDA cleared its IND for simufilam in tuberous sclerosis complex-related epilepsy in September, as it reported Q3 results and a securities settlement escrow payment.
The US biotech's November 2026 corporate presentation reports interim DA-1726 liver-fat data and lays out a timeline running into 2027.
Intellia's Q3 2026 update confirms FDA acceptance of its hereditary angioedema CRISPR therapy filing, alongside completed MAGNITUDE-2 enrolment and a new loan of up to $400 million.
Aptevo reports that successive changes to mipletamig's priming-dose regimen have substantially lowered infusion-related reactions in the RAINIER study, with Phase 2 planned for 2027.
The company plans to start the global Headliner study of micvotabart pelidotin in mid-2027, with FDA feedback on dose selection due in the first quarter of 2027.
Dogwood Therapeutics has enrolled 239 patients in its Phase 2b CINP trial of Halneuron, expects top-line results in November, and raised $5 million from its largest shareholder.
Viatris reported third-quarter revenue of $3.75bn and a GAAP net loss, citing a US approval, a Japanese approval and a product launch.
Armenia's Ministry of Health has authorised Botvymo and Evamplix for previously treated MSS metastatic colorectal cancer, as Agenus reports Q3 2026 results and readies its Phase 3 ROBBIN trial.
An investor presentation proposes pairing the investigational TLR3 agonist with Revolution Medicines' daraxonrasib, though no trial of the combination has been established.
The US company reported a $0.7 million third-quarter net loss, alongside Canadian clearance for its oral testosterone and the start of the BLOOM study of LPCN 1154.
The radiopharmaceutical company reported third-quarter results, cited two FDA approvals and a CMS reimbursement decision, and suspended 2026 guidance because of its pending Curium merger.
The EU regulator has issued a questions-and-answers document for marketing authorisation holders and applicants on the CHMP opinion in the nitrosamine impurities referral, reference EMEA-H-A5(3)-1490.
The medtech group also reports FDA Breakthrough Device Designation for its Freesolve magnesium scaffold and a completed OEM divestiture, with the Intersurgical sale still awaiting regulatory approval.
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.