Latest in Regulatory

TrakCel launches CGT Gateway to streamline cell and gene therapy access for healthcare providers

The gateway will be a single sign-on platform designed to reduce portal fatigue and simplify how healthcare professionals manage cell and gene therapy products, supporting smoother coordination across clinics, networks and stakeholders

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Addressing the biggest problem in clinical trials with data interoperability and AI

This article discusses how data interoperability and artificial intelligence are transforming clinical trials by streamlining data management, improving analysis accuracy and...
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Grifols secures first EU approval for fibrinogen concentrate Prufibry in Germany

Germany has granted the first marketing authorisation for Grifols’ fibrinogen concentrate Prufibry, approved for treating congenital and acquired fibrinogen deficiency

BetaGlue Therapeutics gains MHRA approval for pancreatic cancer trial

YntraDose, the innovative radiotherapy treatment for unresectable locally advanced pancreatic cancer, has been granted an early feasibility clinical investigation and will assess safety and performance in patients

Nanoform granted European Commercial cGMP Manufacturing Licence for APIs

The Finnish company is now authorised to manufacture nanoformed APIs for the European market and for countries in the Middle East and North Africa, Asia and the Americas, where mutual recognition applies to the European license

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

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New draft guidance recommends abiraterone for adults with newly diagnosed high-risk metastatic prostate cancer, marking a major shift driven by lower-cost generics and a more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

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

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

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

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Breaking down silos and building in seamless scale

A Q&A with Kindeva's Tommy Schornak on the Bridgeton facility, Annex 1 compliance and scaling sterile injectable production

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...

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