Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
The regulator has added application details and an expression-of-interest form for the newest cycle of its RWE service, now running as an established offer after a pilot.
Finland's medicines agency has set out how mandates for acting on behalf of a company should be prepared, so retail licence applications come from properly authorised representatives.
Germany's BfArM has posted a Brainlab AG field safety notice for its cranial electromagnetic navigation software, but the listing does not describe the issue or required actions.
Germany's federal medical device authority has listed a manufacturer safety notice for a patient-lifting device, but the hazard and affected units are detailed only in an attached document.
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.
CSL Behring has reported stopper defects in specific Respreeza lots, and AIFA's information note warns of missed doses and possible microbial contamination.
UCB will use Cradle's AI-driven protein engineering platform in selected discovery projects, from hit generation to preclinical readiness, with no financial terms disclosed.
Abc Compounding Co., Inc.'s hand and body wash is subject to recall D-0095-2027, which is ongoing and covers nationwide US distribution, according to the FDA enforcement report.
The recall, numbered D-0111-2027, stems from an interruption in an ongoing stability programme at a third-party laboratory and covers nationwide US distribution.
The US regulator's enforcement report records an ongoing, nationwide Class II drug recall of Lynx, attributed to current good manufacturing practice deviations at ABC Compounding Co., Inc.
An FDA enforcement report entry records an ongoing Class II recall of Delta Foremost Sani-Foam Mango, made by Abc Compounding Co., Inc., and distributed across the US.
The nationwide recall of Aero Foamy Mango Aloe Vera Antiseptic Hand & Body Wash, logged as D-0087-2027, remains ongoing in the FDA's enforcement report.
Glenmark Pharmaceuticals Inc., USA is recalling Abiraterone Acetate Tablets USP 500 mg nationwide; the FDA enforcement report classifies the action as Class II and ongoing.
The recall, numbered D-0106-2027 and still ongoing, covers oxytocin distributed nationwide within the United States, according to the FDA enforcement report.
An FDA enforcement report entry classifies a nationwide US recall of atorvastatin calcium tablets from MSN Laboratories' Unit-II as Class II, citing the presence of foreign tablets or capsules.
The recall, classified for CGMP deviations, is ongoing and covers product distributed across the US, according to the FDA enforcement report.
Eagle Pharma Outsourcing LLC's phenylephrine HCl infusion is subject to an ongoing nationwide US recall, classified for lack of assurance of sterility.
The recall of Certus Medical Satin Foam, entered in FDA's enforcement report on 4 November 2026, is ongoing and covers nationwide US distribution.
The US regulator's enforcement report records an ongoing, nationwide recall of 1-gallon Palm Antiseptic Hand Soap, classed as Class II and attributed to CGMP deviations.
Abc Compounding Co., Inc. is recalling PRO CHEM Fresh Start nationwide under recall D-0097-2027, which FDA classed as Class II and still ongoing.
The nationwide recall, numbered D-0100-2027, is classed as ongoing in the FDA enforcement report dated 4 November 2026.
Abc Compounding Co., Inc.'s hand soap recall, numbered D-0099-2027, is ongoing and covers nationwide US distribution, according to the FDA enforcement report.
An FDA enforcement report entry classifies the Direct Rx Lidocaine Ointment USP recall as Class II for subpotency; the recall is ongoing and covers the whole US.
Abc Compounding Co., Inc. is recalling the antiseptic wash nationwide under recall number D-0086-2027, which the FDA enforcement report shows as ongoing.
The Ritedose Corporation's nationwide US recall of Formoterol Fumarate Inhalation Solution, listed as ongoing, stems from a failed impurities/degradation specification, according to the FDA enforcement report.
An enforcement report entry records an ongoing nationwide recall of SunCoast Paper's Surgent Antiseptic Hand Soap, linked to Abc Compounding Co., Inc. and cited for CGMP deviations.
The FDA enforcement report lists an ongoing, nationwide Class II recall of metoclopramide tablets from Safecor Health, LLC, after a co-mingled tablet was identified.
Abc Compounding Co., Inc. is recalling Freshhands Premium Foamy Antibacterial Hand Soap Antiseptic nationwide, with the action classed as Class II and still ongoing.
The US regulator's enforcement report records an ongoing, nationwide Class II drug recall, numbered D-0101-2027, citing deviations from current good manufacturing practice.
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.