Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
IGJ has published a manufacturer's field safety notice on a software malfunction that lets cobas pro and cobas pure analysers accept erroneous calibrations.
Siemens Healthineers says one production lot of its tox Serum Tricyclic Antidepressant Calibrator Control contains more sodium azide than specified, though it reports no effect on performance.
Austria's BASG newsticker says CMDh has revised its validation advice, updated RMS request templates and flagged which national requirements actually block the start of a procedure.
Austria's latest RMS NEWS reports updated CMDh validation advice, revised RMS request templates for DCP and MRP/RUP, and national requirements now tagged as validation-relevant or not.
Germany's two medicines authorities join the international 2–8 November campaign calling on professionals and patients to report suspected side effects so risks are spotted earlier.
Four lots of the heparin-induced thrombocytopenia antibody assay show negative bias that routine calibration and quality control may miss, and a supply interruption is expected.
AIFA says the EMA safety committee opened a review of hypersensitivity reports linked to immunoglobulin batches and a separate review of Deanxit over serious neurological and psychiatric effects.
Germany's Paul-Ehrlich-Institut has published a Dear Healthcare Professional letter warning that Respreeza's primary container may be compromised, risking missed doses and infections.
EMA's safety committee opened a referral on flupentixol/melitracen and a review of hypersensitivity clusters across all human normal immunoglobulin medicines at its October meeting.
Slovakia's medicines agency has released a direct healthcare professional communication on Caelyx pegylated liposomal, citing possible loss of sterility and unintended exposure when the protective cover is removed.
Baxter Holding B.V. has reported incomplete aluminium crimping on Caelyx 50 mg/25 ml single-dose vials, which can leave the vial open when the cap is removed.
A single lot of Marcan Pharmaceuticals' Cyclophosphamide for Injection USP 1000 mg is subject to a Type I recall in Canada after particulate matter was found.
A single lot of Equate Ultra Strength Antacid Assorted Fruits chewable tablets is recalled nationally in Canada after the possible presence of stainless steel shavings, classed Type II.
The US Bankruptcy Court for the District of Delaware has approved the sale of BioXcel's purchased assets to Teva Pharmaceuticals International GmbH, free and clear of liens and claims.
The EMA has published the single assessment outcome for gliclazide periodic safety update reports, with the marketing authorisations to be maintained, alongside a list of nationally authorised products.
The European Medicines Agency has released the result of a periodic safety update report single assessment for tenoxicam, with the regulatory outcome listed as maintenance.
The EMA has posted the single assessment of periodic safety update reports for nitrofurantoin and nitrofurantoin/pyridoxine hydrochloride, with a maintenance outcome and a list of nationally authorised products.
The EU regulator has posted the single assessment outcome for cystine / pyridoxine hydrochloride, recording a 'maintenance' result for the nationally authorised products concerned.
The European Medicines Agency has issued a list of centrally authorised medicines whose product information has been changed for safety reasons, dated 30 October 2026.
The agency's single assessment of periodic safety update reports for aprotinin ends with a 'maintenance' outcome, and a list of nationally authorised products has been published.
The EMA has published the outcome of the nicorandil periodic safety update report single assessment, PSUSA/00002152/202602, with a regulatory outcome of 'maintenance'.
The MRI-compatible infusion pump maker also lifted net income 17% to $6.5m, narrowed its full-year revenue guidance and declared a $0.20 quarterly dividend.
Pelthos Therapeutics has signed a merger agreement with Castle Creek Biosciences, offering shares and milestone payments tied to FDA approval of the orphan-designated cell therapy D-Fi.
The EMA has published the single-assessment outcome for cyproterone acetate/estradiol valerate under procedure PSUSA/00000907/202603, with a regulatory outcome of 'maintenance'.
The EMA has published the single assessment outcome for furazidine (PSUSA/00011098/202602), with the regulatory outcome listed as maintenance of existing authorisations.
PRAC is assessing the flupentixol/melitracen combination after the Belgian agency raised concerns over severe, lasting movement, memory and thinking side effects and the rationale for combining the two substances.
The European Medicines Agency has released the result of a periodic safety update report single assessment for rabies vaccine, recording a regulatory outcome of 'maintenance'.
The European Medicines Agency has released the single assessment outcome for perchlorates, recording a 'maintenance' result for the active substance under procedure PSUSA/00002486/202603.
The EMA has published the outcome of a periodic safety update report single assessment for diclofenac sodium and orphenadrine citrate, with a regulatory outcome of maintenance.
The company reported Q3 revenue of $83.7 million, up 14%, and has begun a US Phase 4 study of Lupkynis combined with three other lupus nephritis therapies.
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.