All US Food and Drug Administration (FDA) articles – Page 6
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NewsFDA approves new cell therapy manufacturing plant
Bristol Myers Squibb has received approval from the US FDA to begin commercial production at its newest cell therapy manufacturing site.
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ArticleWhat gene therapy manufacturers can gain from collaboration
In this article, Neil Almstead, Chief Technical Operations Officer at PTC Therapeutics, shares his view on why collaboration is key to streamlining manufacture of gene therapies.
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ArticlePsychedelic medicines: are they gaining traction in Europe?
Carissa Kendall-Windless and Sian Banks of law firm Pinsent Masons discuss the development of psychedelic medicines and the legal and regulatory challenges that must be overcome for psychedelics to become safe and effective treatment options in Europe.
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ArticlePrioritising for a data-driven 2023
As the pharmaceutical industry continues to face unprecedented challenges, the need for greater regulatory compliance and process efficiency remains at the forefront. Here, Frits Stulp predicts how new waves of digital transformation can help support companies deliver the best possible patient outcomes.
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NewsFDA approves first treatment for geographic atrophy
The first-ever treatment for geographic atrophy has been approved by the US Food and Drug Administration (FDA).
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NewsPre-filled asthma pen approved for self-administration in EU
Tezspire is the first biologic approved in Europe for severe asthma with no phenotype or biomarker limitation, says AstraZeneca EVP.
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NewsFDA grants priority review of glofitamab for lymphoma
Glofitamab for relapsed or refractory large B-cell lymphoma has been granted priority review by the US Food and Drug Administration (FDA).