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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The US FDA approvals make the drug the first IL-23 inhibitor to be licensed for two common skin conditions.
Jianbo Diao, PhD, Director of Bioanalytical Services, WuXi AppTec, discusses the importance for mRNA therapy developers of adopting precise and flexible analytical strategies for future pipeline success.
The anti-amyloid monoclonal antibody is part of the class of medicines representing the first disease-modifying therapies for the neurodegenerative disease.
uniQure’s positive topline data “are the most convincing in the field to date” and indicate the gene therapy’s potential disease-modifying effects.
The innovative approach facilitates QSRR-assisted chromatographic development for N-nitrosamine analysis in pharmaceutical products.
Advances cell therapy and gene therapy candidates, with both showing neurorestorative potential against the disease.
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.
This in-depth focus features articles on rapid microbiological methods, quality control, and using AI to read agar plates.
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.
EPR Issue 3 includes articles on microbiology, downstream processing, manufacturing, drug formulation and more.
The medicine becomes the first EU-approved oral treatment for adults who have postpartum depression (PPD).
Winners of this year's awards will be revealed during the opening of CPHI Frankfurt 2025.
The ICH Assembly’s decision supports progress in promoting international standards for safety assessment of medicines.
The innovation is set to change how eligible bladder cancer patients in the US are treated who are unresponsive to traditional therapy.
The regulator’s new principles aim to ease the pathway to regulatory approval for rare disease drug developers in the US.