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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.
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Drug Safety
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Gene therapy could improve genetic deafness
The study represents the first time the injectable gene therapy has been evaluated in teenagers and adults.
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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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AbbVie immunology deal to advance potential first-in-class therapy
The new acquisition, worth up to $2.1 billion, gives AbbVie rights to a potential first-in-class drug for B cell-mediated autoimmune diseases.
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Radioligand therapy could address multiple cancer types
The investigational dual-targeting treatment provided strong and durable delivery to tumours, allowing for a high dose of targeted radiation, early results show.
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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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iPSC-CAR-NK cell therapy exhibits autoimmune potential
The genetically edited allogeneic product could serve as an immune-modulatory therapy for severe autoimmune diseases, data suggests.
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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The committee’s final draft guidance cited high-cost as a key reason for its negative opinion of the Alzheimer’s drugs, developed by Biogen and Eisai.
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MHRA Class 2 medicine recalls – May/June 2025
The UK medicine agency's most recent recalls of this class have been due to packaging and potential contamination issues.
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Lancet study illustrates drug delivery “milestone”
The oral pill could address common drug adherence challenges in conditions such as schizophrenia, the clinical trial findings suggest.
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FDA grants expanded approval for hepatitis drug
The FDA’s authorisation helps to address the “significant” remaining need for acute hepatitis C treatments, according to AbbVie.
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Duchenne gene therapy interim trial outcomes “striking”
The gene therapy demonstrated consistent evidence of positively changing disease trajectory in Duchenne muscular dystrophy, new interim data shows.
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MHRA issues first UK guidance on phage therapies
MHRA’s publication is intended to support European developers of phage-based medicinal products to effectively navigate related regulations.
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Pharma Horizons: environmental monitoring
This exclusive report addresses the key obstacles and innovations shaping pharmaceutical environmental monitoring, from QC and contamination control, to the impact of advanced technologies and regulatory changes. Discover practical solutions you can implement to drive progress for your organisation.
