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Portugal's medicines authority has introduced a monthly series analysing therapeutic areas and medicines policy measures, starting with treatments used to prevent and treat migraine.
Decision (2026) 7739 removes Entacapone Orion (entacapone), held by Orion Corporation, from the Union Register; no reason for the withdrawal has been given.
The agency's updated 2026 index covers Ebola donor guidance, immune globulin lot withdrawals, a new Adzynma boxed warning, BabyBIG dosing changes and flu vaccine labelling letters.
From 22 October 2026, five JAK inhibitors for chronic inflammatory diseases can be started and renewed in community practice by the relevant specialists, France's regulator says.
Commission Decision (2026) 7688 of 22 October 2026 authorises Lynavoy, held by GlaxoSmithKline Trading Services Limited, for the EU market.
France's medicines agency has reactivated a temporary substitution framework and asked doctors not to start new patients on quetiapine PR 50 mg, citing manufacturing delays at Pharmathen in Greece.
Austria's medicines authority has added a levofloxacin entry, covering intravenous and oral forms, to its PV template-text page, directing readers to CMDh meeting minutes.
Czech regulator SÚKL has temporarily shut its electronic vigilance reporting interface following a NÚKIB warning about a PHP vulnerability, while reporting duties remain in force.
Italy's medicines agency has revised the eligibility form for serplulimab in first-line ES-SCLC, following publication of Determina DTS n. 57/2026 in the Official Gazette.
Italy's medicines agency says monitoring for Raxone in LHON stops on 22 October 2026, following publication of Determination DTS n. 54/2026 in the Official Gazette.
Italy's medicines agency says monitoring of the Farydak registry stops from 22 October 2026 for its sole listed indication, following a determination published in the Official Gazette.
AIFA announces that, effective 22/10/2026, monitoring will end for the AIFA XALKORI (crizotinib) registry in relation to one specific therapeutic indication, meaning prescribers/pharmacies will no longer need to register patients under that indication through this monitoring tool.
AIFA will close the COMETRIQ monitoring registry for a specific therapeutic indication effective 22/10/2026, ending mandatory data entry requirements for that indication under the AIFA monitored drugs registry system.
AIFA has announced that, effective 22/10/2026, monitoring will end for the ZYDELIG (idelalisib) AIFA Monitoring Registry for specific therapeutic indications, meaning prescribers in Italy will no longer need to use this registry for those indications.
The Dutch inspectorate has published Abbott's field safety notice on the FreeStyle Libre 3 and Libre apps, with a corrective app update still being prepared.
The EU regulator has issued its list setting reference dates and frequencies for periodic safety update report submissions; the entry-level details were not available to VigiEye.
The outcome of the periodic safety update report single assessment for alendronate, procedure PSUSA/00000078/202601, was published on 21 October 2026 and leads to a variation.
Italy's medicines agency has revised the nivolumab registry after a determination was published in the Official Gazette, allowing neoadjuvant immunotherapy in advanced NSCLC settings.
Wedgewood Pharmacy LLC is recalling certain in-expiry compounded veterinary medications at the provider/customer level because inconsistencies were found in the reliability of analytical testing data generated by its laboratory, which could mean potency is not as labelled. The notice text provided is truncated, so the specific products, lots and any adverse events are not stated here and should be confirmed in the full FDA notice.
A periodic safety update report single assessment of intravenous amino acid combinations has ended with a 'maintenance' outcome, according to EMA's publication of 20 October 2026.
The CHMP is assessing whether Rifadin 20 mg/ml oral suspension and syrup should stay on the EU market, as its marketing authorisation holder has not proposed a diethanolamine-free formulation.
A single assessment of periodic safety update reports for hydroxyethyl starch products ends with a 'maintenance' outcome, according to the EMA's 15 October 2026 publication.
The UK regulator has revised its 2014 SSRI and SNRI safety page to reflect a review of how certain risks are explained to patients.
The EU regulator has issued the yearly report of the group of inspectors who work on pharmacovigilance inspection matters, covering the 2025 calendar year.
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.