Pharma & Drug Safety

Ruxolitinib cream for non-segmental vitiligo in people 12+

NICE has published updated technology appraisal guidance (TA1140) on ruxolitinib cream for treating non-segmental vitiligo in individuals aged 12 and over. This guidance replaces previous recommendations and includes information on commercial arrangements for the drug.

Nivolumab for Urothelial Cancer Appraisal Terminated

NICE has terminated the appraisal of nivolumab for urothelial cancer because the company failed to submit evidence. The guidance will be reviewed if the company decides to make a submission in the future.

Philips Respironics BiPAP A40 Pro Ventilator - Discontinuation and Safety Alert

Philips Respironics is discontinuing the BiPAP A40 Pro ventilator globally due to an internal oxygen sensor defect causing false alarms. The company offers patients options for continued care, including device replacement or partial reimbursement. Healthcare providers must inform affected patients of these options.

Curosurf 240 mg/3 ml Suspension Recall by Chiesi SAS

The French ANSM has announced a recall of a specific lot (Lot 1211845, Exp 07/2026) of Curosurf 240 mg/3 ml suspension for endotracheobronchial instillation. This action was initiated by the manufacturer, Chiesi SAS, as a precautionary measure due to a resolved deviation observed during environmental monitoring.

Philips Spectral CT Scanner Software Safety Alert

The French ANSM has issued a safety alert (R2607608) regarding Philips Spectral CT scanner systems with software version 5.1.X. Healthcare facilities using these devices have been notified of a security action initiated by Philips Medical Systems BV.

Leksell Vantage stereotactic system safety information

The French ANSM has issued a safety notice regarding the Leksell Vantage stereotactic system by Elekta Ltd. This action, registered under number R2607991, is based on a safety action implemented by the manufacturer. Affected healthcare facilities have been notified.

ANSM Drug & Device Safety Alert: Endoscopic Clip Device

The French ANSM has issued a safety information notice regarding a recall of specific lots of the Instinct Plus endoscopic clip device by Wilson-Cook Medical, Inc. This action follows a previous safety alert and is registered under ANSM reference R2606331.

ANSM Safety Recall: Autoimmunity IDS SS-A/Ro Reagent

The French ANSM has issued a safety recall (R2532493) for a specific lot of the Autoimmunity IDS SS-A/Ro reagent manufactured by Immunodiagnostic Systems (IDS). Laboratories using this reagent have been notified directly by the manufacturer.

ANSM Safety Information for Hemostasis Reagent STA NeoPTimal 5

The French ANSM has issued a safety information notice regarding the Hemostasis Reagent STA NeoPTimal 5, manufactured by Diagnostica Stago. Affected users have been notified directly by the company, and the action is registered under ANSM number R2607353.

Health Commissioner Statement on Court Ruling and Vaccine Science

New York State Health Commissioner Dr. James McDonald issued a statement on a federal judge's ruling concerning the Advisory Committee on Immunization Practices (ACIP). The statement reaffirms the department's commitment to vaccine science and protection against preventable diseases.