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FDA to pilot faster review of generic drugs manufactured in the US
Sets bioequivalence and active pharmaceutical ingredient (API) requirements for its new ANDA prioritisation programme.
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Regs & Legs
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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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Microbiology/RMM In-Depth Focus 2025
This in-depth focus features articles on rapid microbiological methods, quality control, and using AI to read agar plates.
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Drug development In-Depth Focus 2025
This in-depth focus features articles on cell and gene therapy in Europe and enhancing drug delivery with cost-effective solutions.
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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).
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FDA approves first-of-a-kind intravesical drug delivery system for bladder cancer
The innovation is set to change how eligible bladder cancer patients in the US are treated who are unresponsive to traditional therapy.
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WHO adds cancer and diabetes drugs to its essential medicines list
As an important policy tool, the new editions by the WHO mark a “significant” step in broadening access to new medicines with proven clinical benefits.
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FDA to modernise review process for developers of ultra-rare diseases
The regulator’s new principles aim to ease the pathway to regulatory approval for rare disease drug developers in the US.
