Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
The Danish Medicines Agency expects Epistatus 10 mg oromucosal solution from SERB S.A. to be affected from early to late November 2026, citing manufacturer delays.
The Danish Medicines Agency says production problems are disrupting supply of the live infectious bursal disease vaccine, with disruption expected from late September to mid-December 2026.
Denmark's medicines agency expects supply problems with Trisenox 2 mg/ml arsenic trioxide concentrate from end April to end September 2027, citing production problems at the company.
The Danish Medicines Agency says higher demand is behind disruption to Viatris ApS's gabapentin 600 mg film-coated tablets, with supply expected to be affected from late August to mid-December 2026.
The Danish Medicines Agency says there is no shortage of Pfizer's Rapamune 1 mg/ml oral solution after all, reversing an earlier supply notice.
DKMA's notice on Rimactan 300 mg hard capsules, first posted in March, was updated on 27 October 2026; supply problems began in mid-February with no end date.
DKMA has updated its notice on Sandoz's Rimactan 300 mg capsules, citing increased demand and an expected disruption from mid-February to the end of December 2026.
The Czech regulator's list covers registered products traded between April and September 2026 that receive no public health insurance reimbursement, plus certain products with a set maximum price.
The Czech medicines authority has released the monthly reimbursement list, with maximum prices, reimbursement levels, indication restrictions and change files for products paid by public health insurance.
A federal jury found Sophie Dufort guilty of conspiracy, health care fraud and kickback offences involving forged or purchased prescriptions for braces that beneficiaries did not want or need.
The UK regulator's monthly digest announces new antidepressant patient-information measures and the withdrawal of the IXCHIQ chikungunya vaccine's marketing authorisation, alongside a device safety note on CRRT.
MHRA scientists and the GSK Vaccines Institute for Global Health report that nasal or sublingual delivery of a GMMA-based Strep A vaccine produced immune responses in mice.
The latest monthly release adds to a series of transparency data on the agency's KPIs and expected timelines for specific regulatory functions, running since March 2025.
The UK regulator revised both its open and closed device exemption lists on 27 October 2026, continuing a run of near-weekly changes through the year.
The UK regulator updated its Access work-sharing guidance on 27 October 2026, adding icotrokinra to the table of products approved through the New Active Substance Work Sharing Initiative.
Manufacturers have pulled lots of Alyglo, Gammaked, Gamunex-C and Yimmugo after a higher rate of allergic reactions, some considered medically significant, FDA's biologics centre reports.
The US regulator has directed Takeda to add its most serious label warning to the recombinant ADAMTS13 therapy for congenital TTP after a postmarketing safety signal.
Germany's federal medicines and devices authority has posted a manufacturer advisory on Syriflow MR, but the public listing does not describe the problem or the corrective actions.
Germany's medicines and devices authority has posted a Medtronic Urgent Field Safety Notice for the Abre Venous Self-expanding Stent System, with details held in an attached manufacturer advisory.
Germany's regulator has posted an Urgent Field Safety Notice from Olympus Winter & Ibe GmbH covering four electrosurgical cable products, with details held in the manufacturer's attached notice.
The German regulator has posted a manufacturer advisory covering the aerstent TBY, a non-active special implant, but the public listing does not describe the issue or the affected products.
A Class 2 recall covers every batch of the company's unlicensed clopidogrel oral solution and suspension produced before notification, with patients to be traced and reviewed.
The Nasdaq-listed company says third parties have approached it about its biologics contract manufacturer and that it has hired an investment bank, with no sale yet agreed.
Corxel US and Amanat Acquisition Corp. have signed a business combination agreement, with a roughly $300 million PIPE and about $75 million in trust earmarked for oral obesity candidate CX11.
The bleached paperboard maker refinanced all its debt and booked $17.5M in insurance proceeds, but an Augusta mill disruption extended into October.
The EMA's pharmacovigilance committee has released its recommendations on safety signals adopted at its latest plenary, though the detail was not available at the time of writing.
EMA's pharmacovigilance committee has released extracts of product information wording linked to signals it adopted at its 28 September–1 October 2026 meeting.
Updated Phase 1 data show a 45.5% confirmed response rate in 11 evaluable patients, alongside a high rate of serious related adverse events and three suspected dose preparation errors.
Aptevo says 10 of 47 evaluable newly diagnosed AML patients, initially unfit for intensive chemotherapy, reached allogeneic stem cell transplant after mipletamig plus venetoclax and azacitidine.
Preliminary, unaudited figures show wholesalers bought 792 LYMPHIR units in the quarter to 30 September 2026, with 54 institutions having ordered the lymphoma therapy.
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.