Latest in Regulatory

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

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Excelsior Sciences raises $95m for AI-powered small molecule discovery and manufacturing

Deerfield Management, Khosla Ventures and Sofinnova Partners co-lead Series A fundraising for Excelsior Sciences to accelerate drug discovery and clinical development while...
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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

UK-US pharma deal removes tariffs and boosts access to innovative medicines

The UK has secured a zero-tariff agreement on pharmaceutical exports to the US, alongside major reforms to accelerate NHS access to new treatments

EU approves Sanofi and Regeneron’s Dupixent as first targeted CSU treatment in more than a decade

The European Commission has authorised Dupixent for moderate-to-severe chronic spontaneous urticaria in patients aged 12+, offering the first new targeted option in more than ten years

FDA grants Medivir’s MIV-711 Orphan Drug Designation for Osteogenesis Imperfecta treatment

The FDA has awarded Orphan Drug Designation to Medivir’s selective cathepsin K inhibitor MIV-711 for Osteogenesis Imperfecta, a rare genetic bone disorder, after preclinical and clinical data suggests the therapy may strengthen bone

European Commission approves Teva denosumab biosimilars PONLIMSI and DEGEVMA

The two biosimilars to Prolia and Xgeva will expand access to important bone health treatments across Europe and bolster Teva's strong biosimilars portfolio
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From stockpiles to smart supply chains: how industry wants to fix Europe’s drug shortages

An EU-level stockpile may work, but only if it’s flexible, closely monitored and built with logistics in mind. Industry players say drug security will depend less on volume and more on data, digital oversight and early collaboration throughout the supply chain

FDA gives approval to Novartis' SMA gene replacement therapy Itvisma

Phase III studies demonstrated that a one-time dose of Itvisma improved motor function and stabilisation in patients, potentially reducing the need for chronic spinal muscular atrophy (SMA) treatment

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

QInscribe unveils AI-powered medical writing to revolutionise regulatory submissions

New medical writing service provider QInscribe reduces the time to generate a draft clinical study report (CSR) by 90% with a generative AI solution

Texas sues Bristol Myers Squibb and Sanofi for the alleged deceptive marketing of Plavix

The State of Texas has filed a lawsuit claiming the drugmakers misled patients and healthcare programmes about Plavix’s effectiveness, particularly for minority populations, risking patient safety

Poolbeg Pharma granted European patent for flu drug

POLB 001 targets the body's inflammation machinery and prevents dangerous immune overreactions. The drug could also be used in the treatment of other inflammation-based diseases, such as Cytokine Release Syndrome

BCMPA warns Chancellor: avoid new tax burdens on SMEs in upcoming Budget

The BCMPA is urging the UK Government to ease pressure on small manufacturers by reducing National Insurance costs, cutting red tape and considering SME impact assessments, warning that rising costs and uncertainty are stalling investment and growth

UK pharma shifts as Merck and AstraZeneca scale back: can CDMOs fill the gap?

Recent major site withdrawals and investment pauses have raised concerns about the UK’s industrial strength. But CDMOs say agility, innovation and technical expertise could redefine how and where drugs are made

HHS removes long-standing FDA menopause HRT warnings in landmark move for women’s health in the US

The US Department of Health and Human Services has announced the removal of broad FDA boxed warnings from menopause hormone replacement therapy, following a full scientific review

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

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

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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

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

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