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Build my FeedAmerican Regent is conducting a nationwide voluntary recall of three lots of Epinephrine Injection after reports of leaking and cracked vials. The investigation identified particulate matter, including glass and polymers, and a resulting lack of sterility assurance. The affected lots were distributed across the United States.
The revised assessment covers comminuted wild strawberry leaf preparations, generally used as herbal tea; combinations with other herbal substances are outside scope. Based on traditional use rather than clinical-trial evidence, EMA supports use for minor urinary complaints and mild diarrhoea in adults and adolescents aged 12 years and older, with consultation triggers for persistent symptoms.
The MHRA published an information-only compilation of 15 manufacturer field safety notices covering medical devices and diagnostic products. Entries include ventilators, anaesthesia workstations, infusion pump cassettes, fluoroscopy systems, ostomy pouches, and nucleic-acid or assay products. The page says recipients must act on any FSN they receive and contact the manufacturer with questions.
On 3 September 2026, the G-BA adopted a decision to implement updated STIKO recommendations for travel vaccinations within Germany’s vaccination directive. The decision is not yet effective: it requires BMG non-objection and publication in the Federal Gazette before entering into force. The supplied artifact does not identify the individual vaccines affected.
Swissmedic announced a free English-language online training on registering and managing medical device data in swissdamed. The session will cover registration requirements and timelines, importer links, fees, device transfers, and data downloads, with a recording to be published after the webinar.
Zanvastro (zilganersen) is now approved for pediatric and adult patients with Alexander disease, including patients from infancy through adulthood. The antisense oligonucleotide targets abnormal GFAP production and is administered into the spinal canal every three months. FDA based the decision on controlled and open-label clinical evidence, supported by pharmacokinetic modeling for infants.
EMA has launched an 18-month voluntary pilot for initial marketing authorisation applications. The revised model introduces earlier, structured interactions among applicants, rapporteurs and EMA, including written feedback and a joint EUSTART meeting before submission. It is intended to improve dossier maturity, submission readiness and timeline predictability.
MHRA and Manchester University NHS Foundation Trust launched a regional sandbox to test emerging technologies in live NHS settings under oversight and guardrails. The programme will generate evidence on safety, effectiveness and real-world impact, with initial work expected to include AI-enabled medical devices. Learning may inform broader NHS adoption and proportionate, lifecycle-based regulatory approaches.
The G-BA issued an AMNOG decision for inebilizumab covering a new use in myasthenia gravis for patients who are AChR-antibody-positive or MuSK-antibody-positive. The decision page states that it entered into force on 3 September 2026.
Swissmedic authorised this prescription eye-drop medicine in Switzerland for adults with dry eye whose symptoms are not adequately relieved by other authorised treatments. The product uses serum prepared from the patient’s own blood at 20% or 50%. Evidence suggests symptom relief within two weeks, but data are limited and no clear long-term benefit was shown.
FDA issued an EUA for Capstar (nitenpyram) tablets and revised the existing EUA for generic Nitenpyram Tablets. Both products may now be used to prevent and treat New World screwworm infestations in eligible dogs, puppies, cats, and kittens; the generic product had previously been authorized only for treatment.
EMA has published a consolidated overview of its women’s-health activities across medicine development and regulation. It covers clinical-trial representation, developer support, sex-related assessment and product-information considerations, pharmacovigilance, pregnancy and breastfeeding evidence, and DARWIN EU real-world studies. The page also announces a stakeholder workshop on 28–29 September 2026.
MHRA advises that every parenteral nutrition solution be administered through an integrated or add-on filter, with a pore size no larger than 1.2 μm. A 0.2 μm filter is described as good practice for aqueous/lipid-free solutions. The update follows incidents including a fatal embolism and addresses inconsistent prior guidance.
The §35a SGB V benefit-assessment procedure is marked complete. The decision for Uplizna in adults with generalized myasthenia gravis who are anti-AChR- or anti-MuSK-antibody positive is dated 3 September 2026 and entered into force the same day. The artifact does not state the benefit-rating outcome.
Swissmedic granted a first Swiss authorisation for autologous human-serum eye drops to treat dry eye in adults whose symptoms are not adequately controlled by other authorised treatments. The decision accepted limited evidence: studies suggest symptom relief within two weeks, but longer-term benefit remains unproven. The overall benefit-risk balance was considered favourable.
FDA’s VRBPAC recommended three-virus formulations for the next U.S. seasonal influenza cycle, with separate strain selections for egg-based versus cell- or recombinant-based products. FDA notified approved-vaccine manufacturers of the recommendations and anticipates an adequate, diverse supply.
EMA records that intermittent Saxenda supply shortages associated with increased demand in 2023 and 2024 have been resolved. The update covers liraglutide solution for injection in pre-filled pens at 6 mg/ml and states that information and recommendations issued during the shortage no longer apply.
An MHRA review found inconsistent recommendations for filtering parenteral nutrition and identified adverse incidents, including a fatal embolism. It advises using filters no larger than 1.2 μm for all parenteral nutrition solutions, with 0.2 μm filters good practice for aqueous or lipid-free solutions. Product providers have been asked to align product information.
The G-BA issued a decision under Annex XII of the German Drug Directive for mepolizumab’s new COPD indication. The decision took effect on 3 September 2026. The available HTML confirms the action, but the linked PDF text is corrupted, so the specific benefit-assessment outcome cannot be verified from this artifact.
Swissmedic reports the first Swiss authorisation of Sérum autologue ICH eye drops on 23 February 2026 for adults with dry eye whose symptoms are not adequately relieved by other authorised treatments. Evidence from five trials involving 92 patients suggested symptom relief during the first two weeks versus artificial tears, but the data were limited and no clear long-term benefit was demonstrated. Swissmedic concluded that benefits outweighed manageable risks.
American Regent is conducting a nationwide voluntary recall of three lots of Epinephrine Injection after reports of leaking and cracked vials. The investigation identified particulate matter, including glass and polymers, and a resulting lack of sterility assurance. The affected lots were distributed across the United States.
The revised assessment covers comminuted wild strawberry leaf preparations, generally used as herbal tea; combinations with other herbal substances are outside scope. Based on traditional use rather than clinical-trial evidence, EMA supports use for minor urinary complaints and mild diarrhoea in adults and adolescents aged 12 years and older, with consultation triggers for persistent symptoms.
The MHRA published an information-only compilation of 15 manufacturer field safety notices covering medical devices and diagnostic products. Entries include ventilators, anaesthesia workstations, infusion pump cassettes, fluoroscopy systems, ostomy pouches, and nucleic-acid or assay products. The page says recipients must act on any FSN they receive and contact the manufacturer with questions.
On 3 September 2026, the G-BA adopted a decision to implement updated STIKO recommendations for travel vaccinations within Germany’s vaccination directive. The decision is not yet effective: it requires BMG non-objection and publication in the Federal Gazette before entering into force. The supplied artifact does not identify the individual vaccines affected.
Swissmedic announced a free English-language online training on registering and managing medical device data in swissdamed. The session will cover registration requirements and timelines, importer links, fees, device transfers, and data downloads, with a recording to be published after the webinar.
Zanvastro (zilganersen) is now approved for pediatric and adult patients with Alexander disease, including patients from infancy through adulthood. The antisense oligonucleotide targets abnormal GFAP production and is administered into the spinal canal every three months. FDA based the decision on controlled and open-label clinical evidence, supported by pharmacokinetic modeling for infants.
EMA has launched an 18-month voluntary pilot for initial marketing authorisation applications. The revised model introduces earlier, structured interactions among applicants, rapporteurs and EMA, including written feedback and a joint EUSTART meeting before submission. It is intended to improve dossier maturity, submission readiness and timeline predictability.
MHRA and Manchester University NHS Foundation Trust launched a regional sandbox to test emerging technologies in live NHS settings under oversight and guardrails. The programme will generate evidence on safety, effectiveness and real-world impact, with initial work expected to include AI-enabled medical devices. Learning may inform broader NHS adoption and proportionate, lifecycle-based regulatory approaches.
The G-BA issued an AMNOG decision for inebilizumab covering a new use in myasthenia gravis for patients who are AChR-antibody-positive or MuSK-antibody-positive. The decision page states that it entered into force on 3 September 2026.
Swissmedic authorised this prescription eye-drop medicine in Switzerland for adults with dry eye whose symptoms are not adequately relieved by other authorised treatments. The product uses serum prepared from the patient’s own blood at 20% or 50%. Evidence suggests symptom relief within two weeks, but data are limited and no clear long-term benefit was shown.
FDA issued an EUA for Capstar (nitenpyram) tablets and revised the existing EUA for generic Nitenpyram Tablets. Both products may now be used to prevent and treat New World screwworm infestations in eligible dogs, puppies, cats, and kittens; the generic product had previously been authorized only for treatment.
EMA has published a consolidated overview of its women’s-health activities across medicine development and regulation. It covers clinical-trial representation, developer support, sex-related assessment and product-information considerations, pharmacovigilance, pregnancy and breastfeeding evidence, and DARWIN EU real-world studies. The page also announces a stakeholder workshop on 28–29 September 2026.
MHRA advises that every parenteral nutrition solution be administered through an integrated or add-on filter, with a pore size no larger than 1.2 μm. A 0.2 μm filter is described as good practice for aqueous/lipid-free solutions. The update follows incidents including a fatal embolism and addresses inconsistent prior guidance.
The §35a SGB V benefit-assessment procedure is marked complete. The decision for Uplizna in adults with generalized myasthenia gravis who are anti-AChR- or anti-MuSK-antibody positive is dated 3 September 2026 and entered into force the same day. The artifact does not state the benefit-rating outcome.
Swissmedic granted a first Swiss authorisation for autologous human-serum eye drops to treat dry eye in adults whose symptoms are not adequately controlled by other authorised treatments. The decision accepted limited evidence: studies suggest symptom relief within two weeks, but longer-term benefit remains unproven. The overall benefit-risk balance was considered favourable.
FDA’s VRBPAC recommended three-virus formulations for the next U.S. seasonal influenza cycle, with separate strain selections for egg-based versus cell- or recombinant-based products. FDA notified approved-vaccine manufacturers of the recommendations and anticipates an adequate, diverse supply.
EMA records that intermittent Saxenda supply shortages associated with increased demand in 2023 and 2024 have been resolved. The update covers liraglutide solution for injection in pre-filled pens at 6 mg/ml and states that information and recommendations issued during the shortage no longer apply.
An MHRA review found inconsistent recommendations for filtering parenteral nutrition and identified adverse incidents, including a fatal embolism. It advises using filters no larger than 1.2 μm for all parenteral nutrition solutions, with 0.2 μm filters good practice for aqueous or lipid-free solutions. Product providers have been asked to align product information.
The G-BA issued a decision under Annex XII of the German Drug Directive for mepolizumab’s new COPD indication. The decision took effect on 3 September 2026. The available HTML confirms the action, but the linked PDF text is corrupted, so the specific benefit-assessment outcome cannot be verified from this artifact.
Swissmedic reports the first Swiss authorisation of Sérum autologue ICH eye drops on 23 February 2026 for adults with dry eye whose symptoms are not adequately relieved by other authorised treatments. Evidence from five trials involving 92 patients suggested symptom relief during the first two weeks versus artificial tears, but the data were limited and no clear long-term benefit was demonstrated. Swissmedic concluded that benefits outweighed manageable risks.
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