FDA to encourage new manufacturing sites with its PreCheck programme
The scheme will provide more support and a streamlined application process to companies constructing new US facilities.
List view / Grid view
The scheme will provide more support and a streamlined application process to companies constructing new US facilities.
Amid shifting global dynamics, continued resilience in UK healthcare M&A deal activity is expected in H2 2025, forecasting predicts.
Regulatory pressures and demand for trained operators is expected to hinder growth of the rapid microbiological testing market into the next decade, research suggests.
HHS throws out Pfizer, CSL Seqirus and Sanofi proposals, and will restructure AstraZeneca and Moderna projects.
The novel approach could reduce the industry’s reliance on fossil fuels by offering a sustainable production alternative for pharmaceuticals.
The trial is the first pivotal clinical programme to have met the standard of complete scalp hair regrowth, suggesting potential in immune-mediated diseases.
The proposed transaction means Just-Evotec Biologics’ Toulouse site would be used to develop and manufacture Sandoz biosimilars.
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.
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 landmark regulation establishes a future where highly personalised treatments are part of routine care, says MHRA’s Chief Executive.