Approvals, CHMP opinions, FDA decisions, guidelines, designations and regulatory policy.
The alpha-emitting radiopharmaceutical developer also reported EU orphan status for bamzireotide navoxetan, about $202 million in cash and a Q3 net loss of $32.4 million.
The filing rests on skin frataxin as a possible novel surrogate endpoint, with the Phase 3 FORWARD-FA confirmatory trial still enrolling.
The company also won FDA Breakthrough Therapy status for the drug in major depressive disorder and plans an NDA filing in the first half of 2027.
Annexon's third-quarter update says its C1q inhibitor is under EMA review, a US BLA is due in Q4 2026, and ARCHER II's Month 15 primary endpoint is nearing assessment.
The oral biologics developer also reported $45.3 million in cash at the end of Q3 2026, which it expects to fund operations through at least the end of 2027.
Mereo BioPharma says it is still consulting regulators with Ultragenyx on a setrusumab filing path, while cash of $26.1 million is expected to last into late 2027.
Neurogene says the primary analysis of its NGN-401 Embolden trial will include every dosed participant, with topline results expected in the second half of 2027 and PPQ runs due by year-end.
The company still intends to seek FDA accelerated approval of tralesinidase alfa for MPS IIIB in December, while restructuring its debt and separating its CRHX-101 programme.
ImmunityBio says the FDA has broadened Anktiva's indication to include papillary-only tumours, as quarterly net product revenue rose 53% to $48.7 million.
Praxis Precision Medicines reported Q3 2026 results, with FDA decisions on relutrigine and ulixacaltamide due by 27 December 2026 and 29 January 2027 respectively.
The company says its 505(b)(2) filing for AXPAXLI remains on track after a September FDA meeting, with the SOL-R primary endpoint moved to Week 40.
Asundexian 50 mg tablets are cleared alongside antiplatelet therapy after a recent non-cardioembolic ischaemic stroke or high-risk TIA, with bleeding data shaping the label.
The agency's 4 June 2024 digest covers further recalls of China-made plastic syringes, a Cronobacter safety alert for an infant formula, and a CDER explainer on pharmaceutical quality.
The regulator has refreshed its Innovative Licensing and Access Pathway page, which joins developers, regulators, HTA bodies and the NHS in one route, but the source does not say what changed.
JAZMP reminds CGM users to follow manufacturers' instructions, cross-check unusual readings with a fingerstick meter and report suspected device problems, including near misses.
Three investigational medicines gain entry to the UK's Innovative Licensing and Access Pathway, with applications for the next round open until 11 February 2027.
The agency has released the draft guideline for stakeholder consultation, setting out its expectations for assays used to select patients for treatment.
The UK regulator's Innovative Licensing and Access Pathway, which joins regulators, HTA bodies and the NHS, was updated on 9 November 2026 and continues to accept entry applications.
EMA has published Revision 1 of its draft guideline on assessing the risks of medicinal products in human reproduction and breastfeeding, covering how nonclinical and clinical data are translated into product information. The input gives no detail on specific changes, but the guideline is relevant to how pregnancy, fertility and lactation information is written in SmPC and package leaflet sections, so labelling and PV teams should review the draft and consider whether to comment during consultation.
The manufacturer has begun a field safety corrective action after customers reported ammonia calibration results roughly 6% to 15% too low following a switch of standard lots.
The registrational lymphatic malformations trial is now due to finish enrolling in early Q1 2027, with a rolling BLA planned for the second half of 2027.
The Office of Health Advancement guidance agenda covers combination products, emergency use authorisation, informed consent, paediatric research and orphan designation, with public comment invited.
A direct final rule clarifies that nonclinical tests can include cell-based assays, organs-on-chips and computer models, without mandating any method or changing evidentiary standards.
The Danish Medicines Agency has listed bendroflumethiazide/potassium chloride 2.5+573 mg tablets as in supply failure, opening the way for equivalent foreign-labelled products under section 29(2) of the Medicines Act.
The regulator's new standard covers products whose global marketing authorisations began between 2014 and 2021, with an explanatory note and a downloadable CSV file.
The EMA committee's November meeting also produced five further positive opinions on new products, several variations, and an extension of two avian influenza vaccine authorisations.
The IGJ has released a report on its February 2026 supervisory visit to Stichting Sanquin Amsterdam, but the available description does not set out the findings.
Spain's medicines agency has published its October 2026 CHMP bulletin, listing three positive opinions for new medicines and five changes to products already authorised in the EU.
The UK regulator's guidance page, last updated 6 November 2026, sets out the 60-day notice rule, fees and payment steps for sponsors planning device studies.
The UK regulator's new guidance sets out key regulatory steps for placing SaMD on the market in Great Britain and Northern Ireland, but describes itself as a starting point only.
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.