Latest in Regulatory

CStone's sugemalimab approved by MHRA for Stage III NSCLC

The MHRA's decision marks the biopharma's second indication approved for the product in the UK, with a global commercial rollout for sugemalimab now actively underway

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AI might find the molecule, but delivery decides whether it becomes a medicine

As the pharmaceutical industry scales AI-driven discovery at unprecedented speed, will the early integration of formulation and manufacturability determine which...
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American Chemistry Council's statement to Trump: make chemistry in America again

The Council has released a statement ahead of the President's State of the Union Address, asking for policies that unlock domestic production and address unfair foreign practices

Johnson & Johnson files FDA application for IMAAVY in wAIHA

Johnson & Johnson has submitted an sBLA to the US Food and Drug Administration seeking approval of IMAAVY as the first-ever treatment for warm autoimmune haemolytic anaemia, supported by Phase II/III ENERGY trial data showing rapid and durable haemoglobin response

NICE approves Opzelura cream as first UK treatment for non-segmental vitiligo

Incyte Biosciences UK has secured NICE approval for Opzelura (ruxolitinib) cream, granting eligible NHS patients with non-segmental vitiligo access to the first and only approved therapy in England shown to support facial re-pigmentation

CDA-AMC rejects Leqembi reimbursement despite Health Canada approval

After expressing disappointment about a separate insomnia ruling, Eisai has criticised a draft decision by Canada's drug agency not to recommend public reimbursement of Leqembi for early Alzheimer's disease

Shield Therapeutics’ ACCRUFeR becomes first FDA-approved oral iron for children 10+

The FDA's approval for ACCRUFeR (ferric maltol) to treat iron deficiency in children aged 10 and older makes it the first and only prescription oral iron therapy specifically approved for this pediatric population

Hansa Biopharma’s imlifidase BLA accepted for FDA review

The US Food and Drug Administration has accepted the company's Biologics License Application for imlifidase, a novel IgG-cleaving enzyme designed to enable HLA-incompatible kidney transplantation

Moderna granted marketing authorisation for COVID-19 vaccine in Europe

The product is now Moderna's third in its respiratory vaccine portfolio to be authorised in the European Union, following the approval of Spikevax and mRESVIA

Drug-loaded pellets: unlocking flexible oral dosage design with modern pelletisation technologies

Produced using advanced extrusion–spheronisation technologies such as GEA’s NICA systems, drug-loaded pellets are gaining traction as a flexible and scalable oral solid dosage platform that enhances release control, patient outcomes and manufacturing efficiency

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FDA grants approval for commercial manufacturing at Rezon Bio's Warsaw-Duchnice facility

Rezon Bio announces that its Warsaw-Duchnice facility has received approval from the US Food and Drug Administration (FDA) for the commercial manufacturing of a biosimilar

FDA to review Moderna’s mRNA flu vaccine mRNA-1010 after revised filing

The US regulator has accepted Moderna’s amended biologics licence application for its investigational mRNA flu vaccine, mRNA-1010, assigning an August 2026 decision date

SGS granted approval for resumption of human ADME using carbon-14

The approval allows SGS to resume carbon-14 human ADME studies at its clinical pharmacology unit in Antwerp, reinstating a specialised capability in early-phase clinical research across Europe

FDA refuses review for Moderna's mRNA flu vaccine

Moderna has said that it has received an RTF letter about its next-generation flu shot, a move it has called 'inconsistent' with previous feedback. The company is seeking a meeting with the FDA to determine the next steps

Leqembi subcutaneous formulation granted Priority Review status in China

The Chinese drug regulators' decision to grant Priority Review designation to Eisai’s biologics licence application potentially accelerates approval of the at-home autoinjector option

Hims & Hers backs down on oral GLP-1 copycat after FDA pressure

Facing threats of legal action from Wegovy manufacturer Novo Nordisk and an FDA probe, the health and wellness company has decided to abandon its plans to offer a GLP-1 copycat

ECHA adds two hazardous chemicals to list of substances of very high concern

Companies are responsible for managing the risks of these chemicals and giving customers and consumers information on their safe use

NHS, MHRA and Medicines UK launch Project Revive to tackle medicine shortages

NHS England, the MHRA and Medicines UK have launched Project Revive, a collaborative pilot designed to address critical medicines shortages by fast-tracking dormant MHRA-approved licences and creating dedicated NHS purchasing arrangements to improve long-term supply resilience

En Carta Diagnostics bags FDA Breakthrough Device Designation for EC Pocket Lyme test

The rapid, Point-of-Need molecular diagnostic platform will fill a critical gap in early-stage detection of Borrelia bacteria, the cause of Lyme disease

FDA accepts first quality control standard for mesenchymal stromal cells

The FDA has accepted the first dedicated quality control protocol for mesenchymal stromal cells, recognising the Tasly 3P Characterisation Assay and setting a new regulatory benchmark for MSC safety and clinical performance

3PBIOVIAN secures French CIR certification for Spain and Finland R&D sites

The CDMO has obtained French Crédit d’Impôt Recherche (CIR) certification for its Pamplona and Turku sites, enabling French partners to access tax incentives when collaborating on recombinant protein and advanced therapy projects

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Navigating AI regulation for digital medical devices in global markets

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NJM introduces next-generation Bronco 4 pressure-sensitive labeler

New system simplifies labeling for pharmaceuticals, nutraceuticals and cosmetics

Extract Technology fully integrates into Dec Group and unveils new company name

Dec Group UK reflects unified vision and strengthened capabilities for global customers

testo Saveris 1 update automates environmental monitoring workflows for pharma compliance

Testo Saveris, global leader in measurement solutions, has announced the latest software update for its testo Saveris 1 Environmental Monitoring System, designed to...

New thermal inkjet printer expands AM Labels’ coding portfolio

M2 system delivers high resolution variable data printing at production-line speeds

Why aseptic processing is critical for microsphere drug manufacturing

As microsphere-based drug delivery systems move from niche innovation to commercial reality, manufacturers face growing pressure to guarantee sterility without...

ten23 health QC lab to support commercial product testing for US customer following FDA approvals

This pivotal regulatory milestone enables FDA-compliant release and stability testing for injectable drug products throughout the clinical and commercial phases, in...

Autopack launches modular semi-automatic bucket line

Flexible system helps manufacturers improve efficiency and reduce costs

A-Z Color advances automated quality control in pharmaceutical label production

EyeC inspection systems help deliver zero-error labels and GMP-compliant reliability

ASTM acquires Insight SQC from Sabine River Partners

ASTM International has announced its acquisition of the Insight SQC platform and its customers through an agreement signed in October 2025

Work safely with hazardous substances – new Asecos catalogue available now

Asecos cabinets help minimise risks when storing flammable substances

Piramal Pharma Solutions’ bioconjugates facility in Grangemouth, UK, receives updated MHRA GMP certificates

These certificates cover all activities conducted in the site’s Helix building, including its supporting warehouse and laboratory areas

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