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Amid FDA turmoil Sarepta’s gene therapy worries begin to ease
But the impact of George Tidmarsh’s CBER appointment after Vinay Prasad’s abrupt resignation remains to be seen.
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Regulation & Legislation
news
Broad label FDA approval for phenylketonuria drug
Alongside Phase III data demonstrating significant efficacy in the rare disease, the FDA’s decision could position the small molecule as a future standard of care.
news
EU and US agree preliminary tariffs deal
Marking the first step in the negotiation process, this deal establishes key parameters of the final political agreement on trade and tariffs between the EU and US.
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Pharma Horizons: leading-edge formulation
This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.
news
World-first legislation backs decentralised manufacturing
The landmark regulation establishes a future where highly personalised treatments are part of routine care, says MHRA’s Chief Executive.
news
MHRA approves needle-free allergy drug alternative
The MHRA's approval provides eligible patients with a novel delivery method that is convenient and non-invasive.
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UK Government publishes Life Sciences Sector Plan
While a focus on accelerating access for innovative medicines has been welcomed, industry representatives caution that current system infrastructure could hinder the plans proposed by the UK Government.
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FDA approves first-of-a-kind oral therapy for rare disease
The US drug agency’s authorisation provides hereditary angioedema (HAE) patients with the first new on-demand treatment in over ten years.
article
A rapid microbiological method case study for advanced therapy medicinal products
In this article, Stacey Ramsey, Senior Manager – Microbial Applications Lab, Charles River Laboratories, discusses the modernisation of rapid microbiological methods (RMMs) and the potential of ATP-bioluminescence when testing cell-based products.
webinar
Harnessing AI to transform quality and manufacturing in life sciences
2 July 2025 | By MasterControl
This webinar explores innovative, purpose-built AI solutions that elevate compliance and efficiency in quality and manufacturing operations.
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Novel pre-filled autoinjector receives EU approval
The EU authorisation offers a new treatment option for acromegaly, providing effective disease control and enabling convenient self-administration.
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European Pharmaceutical Review Issue 2 2025
EPR Issue 2 includes articles on the impact of tariffs on the pharmaceutical supply chain, advances in bioprocessing, manufacturing and more.
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Life sciences a “priority sector” in UK Industrial Strategy
The new UK strategy represents a milestone for enhancing international competitiveness and puts into motion the upcoming Life Sciences Sector Plan.
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Regulatory shift signals potential change for future CGT sector
The cell and gene therapy (CGT) sector must maintain its scientific rigor despite recent changes to US policy and market conditions, says key industry body.
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NICE concludes decision for two Alzheimer’s treatments
The committee’s final draft guidance cited high-cost as a key reason for its negative opinion of the Alzheimer’s drugs, developed by Biogen and Eisai.
