Regulatory round-up: 8 August 2026

13 August 2026

Medicines regulators in major international markets have issued a mix of new approvals, safety communications, direct healthcare professional communications, a marketing authorization revocation, a product recall and procedural updates over the past 10 days. Weight management, dermatology, oncology and influenza vaccination account for most of the approval activity.

The latest round-up includes approvals from the US Food and Drug Administration (FDA) and the UK's Medicines and Healthcare products Regulatory Agency (MHRA), safety postings and shortage guidance from the European Medicines Agency (EMA), a final European Commission decision on a rare disease medicine, a batch recall from Health Canada and monthly product information changes from Australia's Therapeutic Goods Administration (TGA). The table below summarizes official human medicines regulatory updates from 4 to 13 August 2026.

Regulatory Round-up

Official human medicines updates from the past 10 days

Country	Regulator	Candidate/product	Type of update	Details	Date	URL
European Union	European Commission	Tavneos (avacopan)	Referral conclusion	The European Commission issued its final decision revoking the EU marketing authorization for Tavneos, following an Article 20 review in which the CHMP concluded that the pivotal Advocate study breached good clinical practice and that its data could no longer support the medicine's efficacy.	04 Aug 2026	Source
United Kingdom	MHRA	Investigational products for liver cancer and dementia	Early access designation	The MHRA granted Innovation Passports under the Innovative Licensing and Access Pathway to investigational products for liver cancer and dementia, opening earlier regulatory and access engagement for the developers ahead of the next application round.	04 Aug 2026	Source
USA	FDA	Orzeyful (oveporexton)	Approval	The FDA approved Orzeyful, an orexin receptor 2 agonist, for adults with narcolepsy type 1, describing it as the first medicine cleared to treat the full range of symptoms of the condition rather than excessive daytime sleepiness or cataplexy alone.	05 Aug 2026	Source
USA	FDA	MFLUSIVA (influenza vaccine, mRNA)	Approval	The FDA licensed MFLUSIVA for the prevention of influenza in adults aged 50 and older, the first mRNA-based flu vaccine cleared in the USA. Use in adults aged 65 and older was granted under accelerated approval, with a confirmatory postmarketing study required.	05 Aug 2026	Source
USA	FDA	Tudriqev (vusolimogene oderparepvec-wtpg)	Accelerated approval	The FDA granted accelerated approval to Tudriqev, an engineered oncolytic viral immunotherapy, in combination with nivolumab for patients with treatment-resistant unresectable advanced cutaneous melanoma, adding a further option after progression on prior systemic therapy.	06 Aug 2026	Source
European Union	EMA	Desogestrel- and etonogestrel-containing medicines	DHPC	A direct healthcare professional communication was disseminated on the risk of meningioma with desogestrel- and etonogestrel-containing contraceptives, setting out risk minimization measures agreed as a variation following the PRAC review of the class.	06 Aug 2026	Source
United Kingdom	MHRA	Rhapsido (remibrutinib)	Approval	The MHRA approved Rhapsido 25 mg film-coated tablets, an oral Bruton's tyrosine kinase inhibitor, for adults with chronic spontaneous urticaria not adequately controlled by antihistamines. The marketing authorization was granted through the International Recognition Procedure Route B.	06 Aug 2026	Source
European Union	EMA	Shortage prevention plans	Guidance update	The EMA published guidance for industry on implementing shortage prevention plans, setting out expectations for marketing authorization holders on identifying supply vulnerabilities and mitigation measures for medicines considered critical to EU health systems.	07 Aug 2026	Source
United Kingdom	MHRA	Photosensitizing and dehydration-risk medicines	Safety communication	The MHRA issued summer advice on medicines that can increase sensitivity to sunlight or the risk of dehydration and heat-related harm, urging patients to check product information and speak to a prescriber or pharmacist rather than stopping treatment.	07 Aug 2026	Source
Canada	Health Canada	Teva-Ectosone 0.1% cream	Recall	Health Canada published a health product recall for Teva-Ectosone 0.1% cream after an affected lot was found to be potentially missing its lot number and expiry date, a labeling defect that prevents traceability and shelf-life checks at the point of use.	07 Aug 2026	Source
European Union	EMA	Litfulo (ritlecitinib)	DHPC	A direct healthcare professional communication set out updated recommendations to minimize the risks of major adverse cardiovascular events, malignancy, venous thromboembolism, serious infections and mortality with Litfulo, alongside a restriction of its authorized indication in alopecia areata.	10 Aug 2026	Source
United Kingdom	MHRA	Foundayo (orforglipron)	Approval	The MHRA authorized Foundayo, a once-daily oral GLP-1 receptor agonist, for weight management in adults meeting specified BMI criteria and for glycemic control in insufficiently controlled type 2 diabetes, making the UK the first country in Europe to clear the tablet.	10 Aug 2026	Source
Australia	TGA	Product information safety updates	Safety update	The TGA published its monthly summary of safety-related product information changes agreed with sponsors, covering the July 2026 reporting period and flagging revised warnings and precautions for health professionals prescribing the medicines concerned.	10 Aug 2026	Source
USA	FDA	Generic Drug User Fee Amendments	Procedural notice	The FDA announced a public meeting on reauthorization of the Generic Drug User Fee Amendments, to be held on 17 September 2026, opening the negotiation cycle that will set generic drug review fees and performance goals for the next five-year period.	10 Aug 2026	Source
United Kingdom	MHRA	Childhood vaccines	Safety communication	The MHRA restated its position on the safety of the routine childhood immunization schedule, pointing to continuous surveillance through the Yellow Card scheme and describing vaccination as among the most effective protections against serious infectious disease.	12 Aug 2026	Source

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