Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
France's regulator has withdrawn one batch each of Biogaran's Afiveg and Advanz Pharma's Mynzepli after a syringe flaw that could cause needle movement or an incomplete intravitreal dose.
CBER's product page for Grifols' nucleic acid test lists a June 2026 approval letter alongside earlier approvals, with the indication covering blood, plasma, organ and tissue donors.
BASG reports a pharmacy-level recall of one Mynzepli 40 mg/ml batch after the marketing authorisation holder identified faulty grip aids on the syringes.
Czech regulator SÚKL has told distributors and healthcare facilities to withdraw a specified batch of Mynezpli 40 mg/ml solution for injection; patients need not return packs.
SÚKL says online offers and intermediary services directing prescription medicines to patients may amount to unlawful mail-order dispensing, and it warns of inspections and sanctions.
Spain's medicines agency has issued its August–September 2026 safety bulletin, covering vitamin D overdose errors, meningioma with desogestrel and etonogestrel, ritlecitinib restrictions and new label safety information.
Class 2 recall EL(26)A/45 targets pharmacy and wholesaler stock after a single complaint of mixed strengths inside a sealed pack.
The IGJ, acting for the health minister, has imposed an administrative fine on Mediahuis NRC B.V.; the published notice does not state the violation or the amount.
EOF has announced the recall of batches 467504, 477651 and 484536 of Pedmarqsi infusion solution; the available notice does not give a reason or recall level.
The EU-level advisory scheme for sponsors preparing clinical trial applications will move from pilot to permanent status, with a final report on about 30 applications due by the end of 2026.
The Czech regulator has told distributors and healthcare facilities to withdraw specified batches of Mitomycin Accord 20 mg powder for solution; patients need not return packs.
Advanz Pharma is recalling two batches of Mynzepli 40 mg/mL pre-filled syringes as a precaution, after a small variation in finger grip size was found that could affect administration.
Italy's medicines agency is checking whether registries active for several years still serve their original purpose, with closures to be announced on its website.
Italy's medicines agency has assigned each marketing authorisation holder's 2025 payback share for direct purchases, with no changes made after consulting companies and payment due within 30 days of effectiveness.
Grifols Deutschland has voluntarily recalled batch G04L046403 of Gamunex 10% infusion solution, according to an information letter published by the Paul-Ehrlich-Institut.
Determination 1531/2026 assigns each marketing authorisation holder's payback burden, by region, with no changes after consultation; payment falls due 30 days after the determination takes effect.
The German regulator has posted a manufacturer safety notice for a femoral knee fusion nail, but the defect, affected lots and required actions appear only in an attached PDF.
Germany's regulator has listed an Urgent Field Safety Notice from Abbott Diabetes Care Ltd. UK for two glucose-monitoring apps, but the entry itself gives no details of the issue.
The automated immunohistochemistry test is FDA-registered as Class I and carries IVDR Class C approval in the EU, and joins Roche's recent MTAP and Claudin-4 assays.
Pritam International Private Limited's Brush Buddies recall, numbered D-0063-2027, is ongoing and covers US nationwide distribution, according to the FDA enforcement report.
FDA's enforcement report lists a Class II recall of Pfizer's levothyroxine sodium tablets after an out-of-specification assay result, with distribution across the US and Puerto Rico.
Right Value Drug Stores LLC's nationwide recall of testosterone cypionate, numbered D-0070-2027, is classed as Class II and remains ongoing, according to the FDA enforcement report.
A nationwide US recall involving Pritam International Private Limited, listed under number D-0069-2027, has been classified Class II for current good manufacturing practice deviations and remains ongoing.
Recall D-0045-2027 covers amlodipine and olmesartan medoxomil tablets distributed nationwide in the US and remains ongoing, according to the FDA enforcement report.
The enforcement report entry, recall D-0059-2027, is ongoing and covers US nationwide distribution of a drug product from India-based Pritam International Private Limited.
Par Health USA's argatroban injection is subject to an ongoing nationwide US recall, number D-0083-2027, after particulate matter was identified in the product solution.
The FDA's enforcement report lists an ongoing nationwide US recall of AvKARE's amitriptyline hydrochloride after the product failed dissolution specifications.
An ongoing nationwide US recall, numbered D-0084-2027, concerns a glutathione injection product named in the FDA enforcement report as Glutathione-L (Greenwich Rx).
Shenzhen Techdow Pharmaceutical's heparin sodium injection recall, numbered D-0050-2027, is listed as ongoing and covers nationwide distribution in the US.
FDA's enforcement report lists a Class II recall of Hikma's Abirtega (abiraterone acetate) USP, with distribution nationwide and the recall still ongoing.
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.