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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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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.
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Roche en route to first continuous delivery treatment for nAMD in Europe
CE mark for Contivue platform supports its ambitions for Susvimo in age-related macular degeneration (AMD).
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Teva wins US obesity approval for its GLP-1 generic liraglutide
And Eli Lilly and Company’s new oral GLP-1 obesity therapy orforglipron shines in late-phase clinical trials.
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Late-stage trial boost for Argenx’s myasthenia gravis drug Vyvgart
The Phase III findings could represent a critical advancement in managing the rare autoimmune disease in those with limited treatment options.
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Sanofi’s Tzield type 1 diabetes immunotherapy wins UK first
Becomes the first monoclonal antibody for the condition to be approved by the MHRA and advances the pharma company’s ambitions in diabetes.
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Daewoong’s microneedle patch marks semaglutide first in obesity
Pharmacokinetic study of the novel drug delivery method shows high relative bioavailability in a once-weekly regimen.
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AI driving automated microbiological testing market growth to 2033
Regulatory pressures and demand for trained operators is expected to hinder growth of the rapid microbiological testing market into the next decade, research suggests.
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New AbbVie data highlights Rinvoq promise in alopecia areata
The trial is the first pivotal clinical programme to have met the standard of complete scalp hair regrowth, suggesting potential in immune-mediated diseases.
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Broad label FDA approval for phenylketonuria drug
Alongside Phase III data demonstrating significant efficacy in the rare disease, the FDA’s decision could position the small molecule as a future standard of care.
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Extension trial demonstrates long-term benefit for Lilly Alzheimer’s drug
The new findings support a limited duration dosing approach and highlight the consistent safety profile for Eli Lilly’s antibody drug.
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Considerations for contact plate recovery in cleanrooms
The study provides greater insight into some of the key factors that affect microbiological surface contamination in cleanrooms.
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Pharma Horizons: leading-edge formulation
This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.
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What will shape the Pharma landscape in Q3 2025?
Upcoming drug approvals and clinical progress will be pivotal during the third quarter of the year, says GlobalData.
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Stanford research illustrates safer stem cell transplants for genetic disease
The innovative protocol could improve stem cell transplants and make them safer, enabling a broader disease population to take advantage of the benefits.
