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FDA draft guidance on biosimilars offers “regulatory relief”
US agency follows in footsteps of European Medicines Agency (EMA) in efforts to streamline biosimilar development.
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Alexion wins EU label expansion for kinase inhibitor Koselugo
Approval provides continuity of care into adulthood for patients with neurofibromatosis type 1 (NF1) using Koselugo (selumetinib) to manage symptoms.
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Why speed and flexibility matter now more than ever
20 October 2025 | By
The balance between speed, scale, and compliance has never been more critical. As GLP-1s, biosimilars, and advanced therapies reshape global priorities, pharma leaders face a new question: how can manufacturing infrastructure evolve fast enough to keep pace?
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Novo Nordisk manufacturing facility, and clients, hit by FDA action
Regulator classifies former Catalent site as ‘official action indicated’, impacting biotech clients such as Regeneron.
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Boehringer’s Jascayd becomes first new IPF treatment in US for a decade
FDA approval for the idiopathic pulmonary fibrosis drug supported by the pharma company’s FIBRONEER phase III clinical trials.
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AI adoption in life science labs faces a growing skills barrier
Pistoia Alliance survey also found that the greatest benefit for lab digitalisation has shifted from efficiency to innovation.
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Call for greater investment and innovation from pharma to address RSV
Despite progress from AstraZeneca, Sanofi, Merck & Co, GSK and Pfizer, analysts say effective respiratory syncytial virus treatments are still needed.
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J&J’s Tremfya secures two paediatric psoriasis approvals from FDA
The US FDA approvals make the drug the first IL-23 inhibitor to be licensed for two common skin conditions.
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Lilly wins European Alzheimer’s approval for Kisunla after regulatory setbacks
The anti-amyloid monoclonal antibody is part of the class of medicines representing the first disease-modifying therapies for the neurodegenerative disease.
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Merck & Co scores European and US wins for Keytruda
The CHMP hands the cancer drug two new recommendations, and the FDA approves its subcutaneous use as Keytruda Qlex.
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Novo Nordisk’s once-weekly diabetes jab Kyinsu set for European approval
EMA advisors at the CHMP backed the combination treatment and also recommended Bayer’s menopause drug Lynkuet, putting both on the path to being licensed.
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Drug development In-Depth Focus 2025
From groundbreaking cell and gene therapies to cost-effective drug delivery innovations, Europe is emerging as a hub for life-changing therapies. Explore expert insights and innovative solutions shaping the pharmaceutical industry.
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Guide to Outsourcing 2025
In this Guide to Outsourcing article, Doug Botkin, PhD Scientific Portfolio Specialist from Charles River Laboratories, examines how modern microbial ID tools can enhance contamination control strategies and explores the benefits an outsourcing partner can provide.
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European Pharmaceutical Review Issue 3 2025
EPR Issue 3 includes articles on microbiology, downstream processing, manufacturing, drug formulation and more.
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Biogen wins European first for depression drug Zurzuvae
The medicine becomes the first EU-approved oral treatment for adults who have postpartum depression (PPD).
