Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
The eye-care company reported nine-month sales of $8.2bn, with dry eye products and surgical equipment launches driving growth, and highlighted its planned purchase of Neurotech Pharmaceuticals.
Eocene's subsidiary has granted Hospital Line SA exclusive rights to market the CE-marked CG-100 intraluminal bypass device in two Mediterranean markets.
The Deep TMS maker reported operating income of $2.6m and 130 systems shipped, and expects full-year 2026 results at the upper end of its guidance.
The Nasdaq- and TASE-listed neurostimulation maker reports third-quarter operating and net profit, 130 system shipments, an $85M backlog and $63.4M in cash.
BioNTech has agreed to pay $205 million in cash for a US priority review voucher, intending to speed FDA review of a future late-stage oncology filing.
The T-cell receptor therapeutics company reports higher research costs and a warrant liability charge, while holding cash and other financial assets of roughly €472M at 30 September.
The company's MD&A for the period to 30 September 2026 points to EP-104GI in eosinophilic esophagitis, with FDA-required trials ahead, and a search for funding or a partner for osteoarthritis.
The cell therapy developer reported Q3 2026 results, with Phase 3 melanoma data due in H1 2027 and cash of $536.3 million funding operations into Q4 2028.
The Nasdaq-listed metal 3D printing firm reports higher cash, lower debt and a revised gross margin outlook, and says it has opened its Forge 1 production campus.
The company's Q3 update puts Phase 2b PACE-1 topline data in the second half of 2027, with two Phase 3 trials planned pending FDA alignment.
The US biotech reported $503.5m in cash after its August IPO, and said FDA feedback supports a fixed-dose Phase 2b trial and a Phase 3 study in non-obstructive HCM.
The US company says net sales of its NPM1-mutated AML therapy rose 53%, and it has agreed a registrational design with the FDA for darlifarnib in HRAS-mutant salivary gland cancer.
The US dermatology company's third-quarter results show first revenue from an online cosmetic product, $5.0 million in cash and a new acne trial ahead of a planned 2027 launch.
The life-sciences tools supplier posted 5% revenue growth and a $158M net loss after a $149M impairment, and forecast FY2027 revenue of $648-660M.
The wound-care device maker says a CMS proposed rule on skin substitute pricing and CPT code 97610 curbed Ultramist system sales, which fell to 40 units from 155.
The maker of the Freedom subcutaneous infusion system posted a small profit, improved its gross margin and trimmed its full-year revenue range while lowering its margin outlook.
The deal brings ZYNRELEF, APONVIE, CINVANTI and SUSTOL under CorMedix, with about $150 million in trailing-12-month net revenue and a Pharmakon term loan backing the purchase.
CMS reversed its proposed nonpayment stance on QTscan diagnostic breast exams, while Middle East conflict delayed shipments and pushed the company to lower its full-year outlook.
Metagenomi plans to open the Phase 1/2 INTEGR8 trial in the first half of 2027, with first clinical data expected in the second half of that year.
Cumberland Pharmaceuticals plans an FDA submission after a pre-NDA meeting, and also reported Phase 2a systemic sclerosis data and Q3 net income lifted by the Apotex transaction.
The agency extended its review of the BLA after classing August's two-year HOPE-3 data and a narrower upper-limb indication as a major amendment, as Capricor reported a wider third-quarter loss.
The company says its Phase 3 IMPROVE-PAH study has approvals in 28 countries, 79 active sites and FDA orphan designation, with interim safety data due in the first half of 2027.
Updated Phase 1 data for the Claudin 6 x CD3 T cell engager show a 5.6-month median PFS, with liver enzyme elevations emerging as a dose-related safety issue.
Inovio says the US regulator cleared its DNA medicine, used with the CELLECTRA 5PSP device, to reduce surgery frequency in adults with the rare airway disease.
Atara Biotherapeutics says the FDA accepted its resubmitted application for tabelecleucel in EBV+ PTLD, while cash of $9.9 million is expected to last into mid-2027.
The company, formerly Achieve Life Sciences, reported Q3 results and said it still expects possible FDA approval of its smoking cessation candidate by the end of Q2 2027.
The US firm's third-quarter revenue was driven mainly by licence income after the FDA approved its blood-based colorectal cancer screening test, which Abbott has since launched.
IsoTis OrthoBiologics is voluntarily removing specific Accell Connexus lots in Canada after possible particulate contamination linked to contact between a ball spring and the mixing container during manufacture.
Health Canada lists a Type I recall of the Surfacer system's Workstation Sheath and Dilator after four complaints, two involving adverse events.
Carestation 850 and 850c systems can deliver a lower concentration of anaesthetic agent than intended, according to a Health Canada recall notice for Datex-Ohmeda, Inc.
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.