Approvals, CHMP opinions, FDA decisions, guidelines, designations and regulatory policy.
Hungary's public health institute says 4,500 Vaxigrip and 2,000 Fluenz doses for 2026/2027 are now available through GPs and paediatricians for eligible young children.
The UK regulator has authorised Incyte's retifanlimab (ZYNYZ) with carboplatin and paclitaxel for adults with inoperable, metastatic or recurrent anal canal cancer, via the International Recognition Procedure.
The agency's refreshed page sets out who must register devices before market placement, with EUDAMED now replacing MHRA registration for most Northern Ireland devices.
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.
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.
The company's CEO said in a media interview that outstanding manufacturing work continues, with resubmission planned as promptly as practicable but no assurance on timing or approval.
The company reported Q3 2026 results for iopofosine I 131 in Waldenström macroglobulinemia, citing an 87.5% response rate in patients treated directly after BTK inhibitor therapy.
Black Diamond Therapeutics reported updated Phase 2 silevertinib data in frontline EGFR non-classical-mutation NSCLC and FDA feedback on a Phase 3 programme that could support accelerated approval.
Humacyte reports Symvess sales of $1.0 million for the third quarter, plans a November dialysis sBLA, and has begun a Phase 2a coronary bypass study.
The US company also reports full enrolment in its OPGx-LCA5 Phase 3 trial and cash of $89.0 million, which it says funds operations into 2029.
After FDA approval in September, Scholar Rock reported $0.6 million in first launch revenue, with EMA and PMDA reviews advancing and a priority review voucher sale agreed for $205 million.
The Dutch health inspectorate has published a bioMérieux field safety notice on the EMAG system, covering references 418591 and 418591U.
Portugal's medicines authority says it held four bilateral meetings and discussed AI, new approach methodologies and patient involvement at the ICMRA summit and plenary, held 3–6 November.
Spain's human medicines committee gave favourable opinions to new generic products, including anticoagulants, kinase inhibitors and diabetes combinations, with the next meeting set for 1 December 2026.
The UK regulator replaced the October 2026 MS and MANSA site registers with November 2026 versions on 10 November, continuing its roughly monthly update cycle.
France's medicines agency has issued an exceptional, temporary substitution recommendation after Sanofi production problems disrupted European supplies of the fixed-dose rifampicin/isoniazid tablet.
The agency's 2026 orphan approvals list for new BLAs covers six products, with approval dates from 26 March to 30 October 2026.
Italy's medicines agency has pushed back the 16 November 2026 deadline for haptens lacking commercial clinical alternatives, keeping them available for allergy diagnosis.
Italy's medicines agency has pushed back the 16 November 2026 deadline for using haptens in patch tests where no marketed clinical alternative exists.
Two Commission Implementing Decisions dated 9 November 2026 add to the lists of harmonised standards references for medical devices and in vitro diagnostics, according to DG SANTE.
Implementing Decision (EU) 2026/2481 changes the 2021 decision listing standards that give manufacturers a presumption of conformity, with sterilisation of healthcare products affected.
Implementing Decision (EU) 2026/2479 updates the list of harmonised standards under the Medical Devices Regulation across seven product and process areas.
Czech regulator SÚKL has approved a variation to STAMICIS 1 mg, raising the heating temperature, shortening incubation, allowing dilution with saline and capping vial withdrawals at ten.
Implementing Decision (EU) 2026/2481 updates the IVDR harmonised standards list for sterilisation of health care products and defers withdrawal of the earlier version of EN ISO 11137-1.
Implementing Decision (EU) 2026/2479 amends Decision 2021/1182, reflecting revised standards on sterilization, clinical investigation, condoms, biological evaluation, washer-disinfectors, electrical equipment and small-bore connectors.
IGJ reports three cases of head tube welds cracking and detaching on the Medema A/S Mini Crosser X-model 3W, with replaced parts in repairs also possibly at risk.
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.