The first new treatment option approved for mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer in decades has been authorised by the US Food and Drug Administration (FDA).
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The increasing complexity of formulations and active biological products raises new challenges for pre-filled syringe development. James Mellman, Device Manager at Novartis, speaks to Nikki Withers about the challenges of selecting the right primary packaging for injectable formulations and how he has learnt to expect the unexpected.
Health Canada has published new guidance for manufacturers of higher-risk 3D-printed medical devices.
Biopharma developers and manufacturers need to know their molecules and understand their manufacturing processes better than ever before. In this article, Mike Wilson discusses the benefits of mass analysis in biopharma and the current challenges of adopting new technologies.
Leading international partner to the biopharmaceutical industry Sartorius Stedim Biotech (SSB) has today announced that the new SIMCA® 16 software for multivariate data analytics is available from its subsidiary Sartorius Stedim Data Analytics.
A $100 million investment has been made to support long-term vaccine manufacturing capabilities in the US.
The FDA has provided guidance on data integrity and compliance; two areas extremely important for pharmaceutical businesses and manufacturers to adhere to...
US FDA commissioner has announced steps to modernise the drug development process to improve efficiency and promote innovation...