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US Food and Drug Administration (FDA)
The FDA has awarded 11 grants equating to about $25 million of funding to clinical trials for the development of rare disease treatments.
Roche's gantenerumab is an anti-amyloid beta antibody developed for subcutaneous administration in Alzheimer’s disease patients.
The draft guidance discusses product development considerations, risk assessments and cGMPs relevant to microbiological control in non-sterile drug (NSD) manufacturing.
In this article, European Pharmaceutical Review’s Hannah Balfour explores some of big pharma’s latest developments in HIV treatment, with commentary from ViiV Healthcare’s Head of Research and Development, Kimberly Smith.
The US FDA amended the emergency use authorisation to allow for a Comirnaty booster dose in individuals at high-risk for COVID-19.
A microneedle patch, which can be stored for >30 days at room temperature, safely delivered a DNA-based COVID-19 vaccine in mice.
Positive results from pivotal trial show that the COVID-19 vaccine Comirnaty is safe and effective in children aged five to 11 years old.
Kisqali plus letrozole achieved a median overall survival of over five years, the longest ever reported for HR+/HER2 breast cancer.
Ampion significantly reduced pain and improved function in severe osteoarthritis of the knee (OAK) in 12 weeks, shows Phase III study.
FDA approves mobocertinib as the first oral therapy for patients with non-small cell lung cancer with EGFR Exon20 insertion mutations.
US FDA have accepted Biologics License Application (BLA) for tislelizumab for the treatment of oesophageal squamous cell carcinoma cancer.
3D printing has the potential to revolutionise the pharmaceutical manufacturing industry; however, few 3D-printed products have been approved since the first in 2015. In this article, EPR’s Hannah Balfour explores the technologies currently being evaluated for use in the 3D printing of pharmaceuticals, and the work of key market players…
Dr Tim Sandle explains that, whether rapid or conventional, documented on paper or computer, microbial methods must have data integrity.