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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The innovation is set to change how eligible bladder cancer patients in the US are treated who are unresponsive to traditional therapy.
Gains access to potential breakthrough atherosclerotic cardiovascular disease biologic therapy pacibekitug.
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.
The regulator’s new principles aim to ease the pathway to regulatory approval for rare disease drug developers in the US.
Significant investment in advanced technologies Is expected to support global adoption of mass spectrometry in the next five years.
European Parliament's SANT Committee urges for greater control on medicine provisions to help strengthen security of supply.
First-of-its-kind case continues EMA and MHRA harmonisation, streamlining the global biosimilar approval pathway.
2 September 2025 | By FUJIFILM Wako Europe GmbH
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And Eli Lilly and Company’s new oral GLP-1 obesity therapy orforglipron shines in late-phase clinical trials.
The Route B notification pilot will expand the MHRA’s risk-proportionate approach and help prepare for a new modifications process under upcoming regulations.
Revisions to the harmonised general chapter “Particulate Contamination (Q-09)” aim to improve pharmaceutical drug development.
The Phase III findings could represent a critical advancement in managing the rare autoimmune disease in those with limited treatment options.
While no other country has an identical scheme, analysis of the 2025 payment rate shows the UK is significantly behind comparable countries.
Contracts to use a facility at Fujifilm’s North Carolina site as part of moves to onshore its manufacturing.
Her leadership experience spans three decades with Lilly, across multiple therapeutic areas including oncology, neuroscience and infectious disease.