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 study provides greater insight into some of the key factors that affect microbiological surface contamination in cleanrooms.
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 novel AI-led approach could accelerate development of Alzheimer’s treatments by reducing related costs.
Recommendation of the once-daily triple therapy increases the number of eligible cystic fibrosis patients who can access treatments in the UK.
While high costs are hindering growth in the lab automation market, research highlights that new innovations like AI offer potential to expand this rapidly evolving industry.
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 US drug agency’s authorisation provides hereditary angioedema (HAE) patients with the first new on-demand treatment in over ten years.
While the pharmaceutical market is expected to witness strong pricing competition, there is also significant opportunity for biotech companies, research says.
The study represents the first time the injectable gene therapy has been evaluated in teenagers and adults.
In this article, Stacey Ramsey, Senior Manager – Microbial Applications Lab, Charles River Laboratories, discusses the modernisation of rapid microbiological methods (RMMs) and the potential of ATP-bioluminescence when testing cell-based products.