Safety signals, PRAC recommendations, DHPCs, Drug Safety Update, MedWatch and risk minimisation.
INFARMED has granted hospital use of dostarlimab with carboplatin and paclitaxel for advanced or recurrent pMMR endometrial cancer and published its public assessment report on Infomed.
Austria's medicines agency has published a pharmacovigilance FAQ entry on how marketing authorisation holders should respond when asked to add safety wording that their product information already contains.
Austria's regulator has added a standard SCAR text to its safety-wording page, pointing to CMDh minutes from the September 2026 meeting.
A Brainlab field safety notice, published by Dutch inspectorate IGJ, says registration may fail or give unusable results in under-twos when Cranial EM is used with Universal Atlas 6.0.
Medtronic has released clinician programmer software 2.1.4148, which includes a firmware update addressing a previously reported fault in which the Vanta implantable neurostimulator stops working after cardioversion.
Philips Medizin Systeme Böblingen has issued a field safety notice after finding its Dual IBP Adapter cannot keep defibrillation protection when two non-defibrillation-proof transducers are connected together.
Version 2.0.3155 or later of the SynchroMed A820 myPTM app addresses delays reported by patients using the PTM with SynchroMed II and III infusion pumps.
The Dutch inspectorate IGJ has published a Philips field safety notice saying some Azurion image-guided therapy systems may have been fitted with solid-state drives not listed in the medical device file.
CBER is assessing whether regulatory action is needed after postmarketing malignancy reports, and says the neoplasia risk applies to both onasemnogene abeparvovec products, Zolgensma and Itvisma.
Spain's regulator says a motor shaft break combined with a faulty Single Fault Safety system could cause patient falls or sudden descents; Baxter is inspecting affected units.
AIFA's monitoring report puts public drug expenditure at 19.26% of the national health fund for the first four months of 2026, based on a provisional fund value.
IGJ has released an inspection report on Crinetics Pharmaceuticals Europe GmbH in Amsterdam, but the available material does not disclose findings, required measures or the type of inspection.
AEMPS says its veterinary committee gave favourable opinions on four marketing authorisation applications on 14 October; formal authorisation decisions are still to be issued by the agency's management.
The UK regulator proposes more frequent ECG and electrolyte checks for givinostat, with implementation subject to an ongoing independent review; no deaths have been reported in the UK.
The European Medicines Agency has released the outcome of a periodic safety update report single assessment for diethylamine-salicylate/escin, with the regulatory outcome listed as maintenance.
The EU regulator has issued a questions-and-answers document for marketing authorisation holders and applicants on the CHMP opinion in the nitrosamine impurities referral, reference EMEA-H-A5(3)-1490.
The EMA has published the single assessment outcome for the ethinylestradiol/gestodene combination, with a regulatory outcome of maintenance and a list of nationally authorised products.
A manufacturer notice published by Dutch inspectorate IGJ describes how the analyser can place samples from two patients in one IFE block when diluent runs short.
The UK regulator's new corporate plan sets out how patients, carers and the public will be involved in its decisions, building on the 2021-2025 strategy.
Kyle Diamantas says the agency approved 28 novel rare disease drugs and biologics in the past year, while nearly 95 percent of patients still lack an approved treatment.
CSL Behring has reported stopper defects in certain Respreeza batches that could prevent administration or allow microbial contamination, prompting a quality-related communication to healthcare professionals.
Greece's EOF reports that the EMA safety committee is examining batch-specific allergic reactions with immunoglobulin products and has opened a separate review of Deanxit.
The agency's CY 2027 final rule, CMS-1848-F, amends the Medicare Shared Savings Program with the aim of speeding up accountable care and linking spending to value.
The US agency says the final rule moves Medicare payment emphasis towards preventive care and away from treating illness, while curbing waste; provision-level detail is not yet clear.
The Medicare final rule sets 2027 hospital outpatient and ASC payment rates, widens outpatient surgery options and lowers beneficiary out-of-pocket costs for certain services.
The US Centers for Medicare & Medicaid Services published final rule CMS-1844-F on 4 November 2026, setting annual Medicare payment policy updates for home health agencies.
The US agency says the final rule strengthens its authority to recover Medicare payments, clarifies home palliative care access and accelerates public quality reporting, with savings expected in the tens of millions of dollars.
ŠÚKL has released a Direct Healthcare Professional Communication on Respreeza, citing possible compromised injection vial integrity that could lead to a missed dose or potential infection.
A Dutch inspectorate notice says Getinge's D.03 software slows the compressor during autofill, potentially lowering vacuum and triggering an alarm that prevents Cardiosave pumps from starting or resuming therapy.
Compact Medical is removing nine ButterflyBVM lots and applying a pre-use test correction to 22 others after holes were found forming in the bellows.
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.