Latest in Regulatory

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

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Beckman Coulter Life Sciences partners with Automata for AI-ready lab automation

The pair will integrate advanced liquid handling and analytical technologies with AI-ready, modular laboratory automation, enabling faster, more scalable and data-driven...
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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

Shilpa Medicare targets US approval for extended-release Ondansetron injection for CINV

Shilpa Medicare plans to pursue US approval and licensing partners for OERIS after a Phase III study in India met all primary and secondary endpoints and showed a strong safety profile in chemotherapy-induced nausea and vomiting

MedPharm completes FDA inspection of manufacturing plant in Durham

The topical drug product manufacturing facility in North Carolina successfully completed its FDA inspection for the commercial manufacture of drug products with no Form 483 issued plus an NAI classification

Ascletis secures FDA IND clearance for Phase II Study of oral GLP-1 candidate in type 2 diabetes

Ascletis has received US FDA IND clearance to begin a 13-week Phase II trial of ASC30, its oral small-molecule GLP-1 receptor agonist, evaluating efficacy, safety and tolerability in people with type 2 diabetes

Novo Nordisk wins positive ruling for semaglutide compound patent from China’s Supreme People’s Court

The company has welcomed a decision by China’s Supreme People’s Court affirming the validity of its semaglutide compound patent, strengthening confidence for foreign drugmakers operating in the Chinese market

Grifols receives US FDA approval for new fibrinogen concentrate: FESILTY (fibrinogen, human-chmt)

The fibrinogen concentrate complements Grifols’ bleeding management portfolio, expanding therapeutic options for patients

LYOVAC® ECO Mode: making pharmaceutical freeze-drying leaner and greener

Following the recent announcement that GEA Lyophil has received third-party certification for the energy-saving credentials of its innovative algorithm for freeze-drying applications, Dr Kevin Robinson caught up with Senior Director of Lyophilization Technology Management, Thomas Beutler, to find out more

Latest posts in Regulatory

Hansa Biopharma submits BLA to FDA for Imlifidase in desensitisation for kidney transplantation

Imlifidase is an enzyme that rapidly and efficiently cleaves all types of immunoglobulin G (IgG) antibodies both intra- and extra-vascularly to inhibit IgG-mediated immune response

New pharmaceutical legislation in Europe agreed

The agreement is the most significant overhaul of the regulatory framework in more than 20 years and represents a huge opportunity to reshape medicines regulation in the EU

Grifols gets nod from European Medicines Agency for entire value chain of Grifols Egypt

The institution's certification endorses the entire plasma value chain under the highest European standards and opens the door for Egypt to, once domestic needs are met, export to other markets including Europe

Regulating innovation: a new focus on digital mental health technologies (DMHTs)

IMed Consultancy’s Benjamin Austin provides a clear understanding of how digital mental health technologies are innovating care and describes the evolving regulatory frameworks that ensure their safety and effectiveness

FDA considers black box warning for COVID-19 vaccines amid internal disputes

The US FDA is reportedly weighing a black box warning for COVID-19 vaccines — a move that has alarmed public health leaders and vaccine manufacturers, who say no new safety signals support such action

BIOSECURE Act on track to curb Chinese biotech investment in the US

The amended Act was included in the annual defence bill after failing to pass muster in the last key defence spending bill, but has some notable omissions

One in four European pharma companies at risk of regulatory breaches according to NSF research

The independent survey exposed significant gaps in quality systems, supply chain oversight and data integration, just as EU GMP regulations continue to tighten

NICE raises cost-effectiveness thresholds to boost UK pharma innovation

The UK government has confirmed that NICE will increase its cost-effectiveness thresholds to £25,000-£35,000 per QALY from April 2026, with the aim to support pharmaceutical companies and unlock patient access to new medicines

BIA urges new UK access pathway to speed innovative rare disease medicines to NHS patients

The BioIndustry Association (BIA) has called for a connected, flexible UK pathway to improve access to innovative rare disease medicines, as outlined in a new report released in London

AstraZeneca's New Drug Application for hypertension drug accepted under FDA Priority Review

Baxdrostat has had positive Phase III trial results and, if approved, could be the first aldosterone synthase inhibitor to receive regulatory authorisation

NOAH calls for Veterinary Medicines Agreement amid concerns over Northern Ireland veterinary medicines supply changes

With EU regulations set to apply fully from 1 January 2026, Northern Ireland could see 10-15% of veterinary medicines discontinued. Industry and government are working on mitigation schemes to protect animal health and ensure continued access to essential treatments

Sponsor content

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

Updated MHRA GMP certificates strengthen Piramal’s bioconjugates capabilities at Grangemouth

Certification renewal supports clinical and commercial ADC development and manufacturing

Redefining QP training for today’s professionals

How NSF is making specialist learning more flexible and accessible

NSF’s QP training program combines technical skill with personalised guidance

A mentoring-led approach supporting delegates through every stage of the QP journey

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