Latest in Regulatory

diaago receives ISO 9001:2015 certification for its corporate Quality Management System

The internationally recognised certification confirms diaago’s dedication to delivering consistent, high-quality products and services to the scientific community

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Three ways AI is changing the chemicals and materials industry

With AI technologies continuing to make their mark on almost every sector, the materials and chemicals industry is no exception, reports Cameron Ross, Senior Vice President of...
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NICE backs generic abiraterone for advanced prostate cancer in move set to benefit thousands and save NHS millions

New draft guidance recommends abiraterone for adults with newly diagnosed high-risk metastatic prostate cancer, marking a major shift driven by lower-cost generics and a more dynamic approach to keeping NHS care up to date

Crown Bioscience achieves second CLIA certification of 2025 at Suzhou Laboratory

Regulated by the Centers for Medicare and Medicaid Services (CMS), CLIA certification sets the highest federal standards for laboratory accuracy, reliability and quality

Immusoft receives FDA Fast Track Designation for ISP-001, a first-in-class engineered B cell therapy for MPS I

Immusoft’s ISP-001, designed to deliver continuous enzyme production through engineered B cells, becomes the first clinical-stage therapy of its kind to receive FDA Fast Track designation

MoonLake Immunotherapeutics faces Securities Class Action after disastrous Phase III trial results

The announcement about the trial results for the product candidate sonelokimab, a highly anticipated treatment for patients with skin disease, saw MoonLake investors' shares fall by about 90%, prompting an investigation into whether or not they were misled

NAD+ supplement claims under scrutiny as Niagen Bioscience wins landmark advertising case

The National Advertising Division (NAD) has ruled against Reus Research over unsupported NAD+ product claims, reinforcing that oral NAD+ ingestion lacks scientific backing and affirming Niagen’s clinically proven approach

FDA grants Breakthrough Therapy designation to BeOne Medicines' sonrotoclax

The designation comes after positive early results of a Phase I/II study in patients with relapsed or refractory mantle cell lymphoma, with BeOne aiming to participate in Project Orbis programme to advance global access

Zelluna receives positive MHRA feedback and advances UK clinical plans for ZI-MA4-1

Zelluna has secured alignment with the UK’s MHRA on the clinical and regulatory pathway for its TCR-NK therapy ZI-MA4-1, paving the way for a CTA submission by the end of 2025 and first-in-human trials at The Christie and The Royal Marsden in 2026

Aseptic spray drying: Transforming biotherapeutics for a new era

With interest in aseptic spray drying on the rise in the pharmaceutical industry, Dr Kevin Robinson spoke to GEA’s David Costes about how the company is combining process, engineering and technological expertise with market insights to provide a safe, reliable and high-performance technology for advanced biotherapeutic powder applications

Latest posts in Regulatory

Quality control: the central pillar supporting peptide manufacturing

Amid the growing complexity and innovation in the field, this article explores how centralised quality control plays a pivotal role by ensuring both safety and consistency during custom peptide production

FDA lifts clinical hold on Neurizon’s NUZ-001 for ALS trial entry

The decision clears the path for NUZ-001 to join the HEALEY ALS Platform Trial later this year, advancing Neurizon’s lead therapy for amyotrophic lateral sclerosis and strengthening its regulatory and development pipeline

Novartis secures FDA approval for Rhapsido, the first oral BTKi treatment for chronic spontaneous urticaria

Rhapsido (remibrutinib) offers a new targeted option for CSU patients, showing rapid symptom control and a favourable safety profile without lab monitoring, as Novartis expands its immunology portfolio

Pfizer strikes landmark deal with US government to lower drug prices

The agreement ensures Americans pay less for medicines while giving Pfizer tariff certainty and a clear pricing framework, enabling $70bn in US investment and a renewed focus on next-generation therapies in cancer, obesity, vaccines and immunology

Trump warning: drugmakers must expand US manufacturing or face tariffs

The president announced a new 100% tariff on branded medicines unless manufacturers are already building US plants

AbbVie submits new drug application to FDA for tavapadon in Parkinson’s disease treatment

The once-daily oral dopamine D1/D5 receptor partial agonist has been supported by positive Phase III TEMPO trial results that show symptomatic improvement across the Parkinson’s disease spectrum

EDQM to play key role in strengthening African medicines regulation

This initiative marks a significant step forward in global regulatory co-operation and reflects the EDQM’s commitment to promoting access to safe and effective, high-quality medicines worldwide

FDA authorises OGT companion diagnostic for acute leukaemia

The emergence of precision therapies, such as the menin inhibitor Revuforj (an oral inhibitor of the menin–KMT2A interaction), offers new avenues to improve outcomes for patients with these challenging acute leukaemia cases

CHMP recommends Sanofi and Regeneron’s Dupixent to treat chronic spontaneous urticaria in EU

If approved, it would be the first targeted CSU therapy in the EU in more than a decade, supported by Phase III LIBERTY-CUPID data showing significant itch and hive reduction at 24 weeks

Biocon Biologics wins FDA approval for Bosaya and Aukelso, denosumab biosimilars to Prolia and Xgeva

The approvals mark a major step in Biocon’s mission to deliver affordable, high-quality biologics, with Bosaya offering a cost-effective treatment for osteoporosis and Aukelso expanding access to oncology care for patients with bone-related complications
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Cloud labelling and serialisation: the new frontline of traceability in drug delivery

As drug delivery evolves to accommodate a new wave of data-driven innovation, the need for traceability and compliance throughout the supply chain is paramount. Innovative cloud-based solutions enable pharmaceutical companies to navigate these demands with confidence

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TurboFil offers industry-leading glove testing systems

Partnership with RAVONA delivers precision and compliance in aseptic environments

How to execute a successful remediation strategy

NSF’s experts share guidance on building sustainable compliance and avoiding quick fixes

How to optimise your quality culture and maturity for success

NSF outlines how aligning culture, leadership and systems can strengthen compliance and performance

Compliance ≠ Quality: why “meeting the standard” isn’t enough

In pharma manufacturing, regulatory compliance is non-negotiable. Whether it’s 21 CFR Part 11, EU Annex 11, or PIC/S PE-009, every manufacturer understands the need for...

Shimadzu launches ALTRACE energy dispersive X-ray fluorescence spectrometer

High-sensitivity analysis and automated measurements for food, environmental, and pharmaceutical inspections

Abzena advances immunogenicity risk assessment in biologic drug development

New white paper explores how early testing helps predict and prevent unwanted immune responses in therapeutic proteins

Piramal Pharma Solutions awards Riverview and Digwal for patient centricity

Two sites recognised for innovative initiatives that put patients first

FDA US agent services backed by regulatory expertise

Helping medical device companies achieve smooth US market entry

What to expect from a regulatory inspection

NSF’s expert guide outlines key expectations, common pitfalls and strategies for lasting inspection readiness

A blueprint for Digital Health Medical Technologies (DHMTs)

Understanding compliance for digital mental health technologies

Analytical vigilance saves lives

The EDQM has updated Ph. Eur. monographs to detect ethylene glycol and diethylene glycol. Butterworth Laboratories supports compliance through validated chromatographic...

Balancing integration strategies for stable cell line development

Abzena compares random vs semi-targeted approaches for biologics production

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