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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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.
The new findings support a limited duration dosing approach and highlight the consistent safety profile for Eli Lilly’s antibody drug.
The new appointee has over twenty years of experience in biopharma and extensive senior expertise in oncology.
This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.
Upcoming drug approvals and clinical progress will be pivotal during the third quarter of the year, says GlobalData.
The innovative protocol could improve stem cell transplants and make them safer, enabling a broader disease population to take advantage of the benefits.
The new deal could support innovation of next-generation combination vaccines to protect older adults against multiple respiratory viruses.
The new partnership between Boehringer Ingelheim and LEO Pharma aims to expand treatment access for more patients with generalised pustular psoriasis.
The novel AI-led approach could accelerate development of Alzheimer’s treatments by reducing related costs.
While a focus on accelerating access for innovative medicines has been welcomed, industry representatives caution that current system infrastructure could hinder the plans proposed by the UK Government.
Recommendation of the once-daily triple therapy increases the number of eligible cystic fibrosis patients who can access treatments in the UK.
Following their recent LinkedIn Live, Hexagon’s Adam Cross, Industry Director for Pharma and Life Sciences, reveals the state of data in pharmaceutical manufacturing, the opportunities available and how companies can ensure success and sustainable outcomes in their digitalisation journey.
The expanded agreement between ViiV Healthcare and Medicines Patent Pool (MPP) provides a more patient-centric treatment approach for HIV patients worldwide.
Based on the clinical trial results, the drugs could particularly benefit tuberculosis patients requiring extended therapeutic intervention.
After their recent webinar, European Pharmaceutical Review’s Head of Content Ian Betteridge spoke with the team at Adragos Pharma to discuss the role of a CDMO and their importance in the fill and finish sector.