Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
Health Canada lists a Type II recall of several Azurion 7 configurations after surge voltages during start or restart can disable internal power supplies and leave systems unusable.
QuidelOrtho has confirmed that certain generations of Vitros A1c slides may produce positively biased results, with 58 complaints received and no adverse events reported as of 15 October 2026.
The US company also signed an option deal with Generian for an oral FcRn antagonist and appointed Sheila Gujrathi as Executive Chair after acquiring Vidya Therapeutics.
Alnylam reports $1,292m in global net product revenue for Q3 2026, widens its Phase 3 nucresiran study in ATTR-CM and flags a pivotal Huntington's programme for 2027.
Subsidiary Cyclo Therapeutics has submitted an NDA and requested a rare pediatric disease priority review voucher, although the TransportNPC trial did not meet its primary endpoint overall.
The US biotech has amended its Phase 1/2 study of the topical live biotherapeutic beyond EGFR inhibitor rash and shortened antibiotic and steroid washout periods to ease recruitment.
Interim Phase 1b data for the investigational CCR8 antibody, given with toripalimab, show high response rates in a small first-line cohort and no new safety signals.
The breast aesthetics medtech reported US sales up 119% and its first quarter of positive operating and free cash flow, with FDA review of Motiva for reconstruction on track.
The agreement covers work at Celularity's New Jersey site, but supply to US compounders depends on FDA adding the peptides to its bulk drug substances list.
Indivior's third-quarter revenue rose 13% to $356m, driven by a 22% rise in Sublocade sales, with the all-stock Supernus deal expected to complete on 2 November.
The contract research organisation reported $691.5M in third-quarter revenue and narrowed its 2026 guidance, lifting the midpoints for both revenue and adjusted EBITDA.
The maker of semiconductor-based ultrasound devices reported a record 73% gross margin and a narrower net loss, and said it has secured FedRAMP authorization.
The US company will pay $3.5 million upfront for rights to mitucapistat and aims to start a multinational Phase 3 trial in central retinal artery occlusion in 2027.
The technology services provider reported third-quarter revenue of $5.66 billion, raised its Project Leap restructuring cost estimate and announced a five-year extension of its work with Gilead Sciences.
Bristol Myers Squibb lifted its full-year revenue outlook as Growth Portfolio sales rose 12%, citing the approval of Zenbexus and positive late-stage iza-bren data.
The US company's 29 October presentation addresses commercial progress for ARIKAYCE and BRINSUPRI and clinical updates on TPIP, though the available excerpt gives no financial figures.
Phathom kept its full-year VOQUEZNA guidance at $310–325 million while a US court allowed it to intervene in BDR Pharmaceuticals' suit over the drug's NCE exclusivity.
Eli Lilly reported third-quarter revenue of $24.4bn, driven mainly by Mounjaro and Zepbound, and cited several recent US FDA approvals alongside higher full-year guidance.
The medtech group reported growth both as reported and organically, a lower adjusted profit on a higher tax rate, and the retirement of $864m of debt through a tender offer.
Insmed lifted the low end of 2026 sales guidance for Brinsupri and Arikayce, while the FDA set a January 2027 PDUFA date for an Arikayce label expansion.
The EphA2-targeting Bicycle Drug Conjugate received the US designation in September 2026, while the company reported $469.9 million in cash and a $10.5 million third-quarter net loss.
Keytruda, Winrevair and Animal Health drove Merck's third-quarter growth, while the FDA accepted a priority-review filing for sacituzumab tirumotecan in advanced or recurrent endometrial cancer.
The US biopharma company reported strong third-quarter growth led by Opzelura and its haematology/oncology portfolio, and lifted full-year net sales guidance for several categories.
The royalty-focused biopharma company reported a GAAP net loss of $28.5m for the quarter and raised adjusted diluted earnings guidance, while reaffirming its revenue outlook.
Olympus Winter & Ibe says 19 further monopolar and bipolar HF cable models may share a defect linked to a minor burn; the Dutch inspectorate IGJ has published the notice.
The Czech regulator's quality defects department has told distributors and healthcare facilities to withdraw a specified batch of Mynzepli 40 mg/ml solution for injection; patients need not return packs.
The manufacturer has voluntarily withdrawn the affected batches, saying the particles pose an unacceptable risk to the safety and performance of the syringes, according to the Dutch inspectorate IGJ.
Germany's regulator has posted a manufacturer notice on the ENT device but its own entry gives no detail on the problem, affected units or actions required.
Germany's regulator has listed an urgent field safety notice for two TruSystem surgical devices, but the hazard and required actions appear only in the manufacturer's attached advisory.
Germany's regulator has published a manufacturer advisory covering Sebia's HYDRAGEL 7 ISO-PAL and HYDRAGEL 15 ISO-PAL, but the public listing gives no detail on the issue.
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.