The US Food and Drug Administration has authorised the emergency use of COVID-19 vaccine Comirnaty in children aged five to 11 years.
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Study finds Broadband Acoustic Resonance Dissolution Spectroscopy (BARDS) to be a potentially more time-efficient and cost-effective method for solid dose stability testing.
EMA's drug safety committee (PRAC) assessed risks with COVID-19 vaccines and identified no risk of death with Imbruvica and ACE inhibitors.
Machine vision-based concentration determination enabled the accurate real-time monitoring and control of continuous powder blending.
New research shows co-processed excipient is superior to non-co-processed when using near infrared (NIR) process analytical technology (PAT) to monitor direct compression tableting.
PaxMedica's intravenous (IV) suramin known as PAX-101 had mixed results in Phase II study, but shows potential to reduce autism symptoms.
The consortium also consists of 10 pharmaceutical companies and five organisations to accelerate gene therapies to treat rare diseases.
The single-arm study showed that radiation therapy is an effective noninvasive alternative treatment for renal cell carcinoma (RCC).
Two new analyses displayed positive data supporting Stelara for the treatment of Crohn's disease and ulcerative colitis.
The European Medicines Agency (EMA)'s human medicines committee (CHMP) concludes that a booster dose of Spikevax can be administered in adults aged 18 or over.
Research shows size exclusion chromatography (SEC) with mass spectrometry (MS) enables the simple, quick and reliable analysis of antibody-drug conjugates (ADCs).
The UK regulator concluded that breast cancer patients taking tucatinib live longer, but it is unclear how long for and whether it is cost effective.
The model determines cyclodextrin complex stability constants as a function of pH and temperature, helping to optimise formulations using cyclodextrin.
The European Medicines Agency's human medicines committee (CHMP) begins its rolling review of the investigational oral antiviral molnupiravir.
The FDA has released new draft guidance: “Data Standards for Drug and Biological Product Submissions Containing Real-World Data.”