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.
List view / Grid view
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.
Based on the clinical trial results, the drugs could particularly benefit tuberculosis patients requiring extended therapeutic intervention.
The top-line Phase III findings illustrate potential of the monoclonal antibody plus chemotherapy as a first-line gastric cancer treatment.
The study represents the first time the injectable gene therapy has been evaluated in teenagers and adults.
2 July 2025 | By MasterControl
This webinar explores innovative, purpose-built AI solutions that elevate compliance and efficiency in quality and manufacturing operations.
The new acquisition, worth up to $2.1 billion, gives AbbVie rights to a potential first-in-class drug for B cell-mediated autoimmune diseases.