Dupixent is the first and only medicine indicated to treat eosinophilic esophagitis in the United States; approval granted more than two months ahead of USFDA’s Priority Review action date
Positive opinion could expand the role of Cosentyx (secukinumab) in reducing flare risk in pediatric enthesitis-related arthritis (ERA) and psoriatic arthritis (PsA) patients in the EU
The partnership will further strengthen Olympus leadership in the diagnosis and staging of liver disease
Purpose-built bioconjugation facility in Lonza’s Ibex Dedicate Biopark in Visp, Switzerland to support the potential commercial launch of Kodiak's lead product candidate KSI-301 for high-prevalence retinal diseases
The icare4u program features a dedicated website, with comprehensive information about the diseases, videos with medical experts, and a social media community for patients and caregivers on Facebook and YouTube
The vaccine was found to have 64% efficacy against symptomatic disease and 92% against severe Covid-19
Phase I trial in Rwanda and South Africa aims to evaluate mRNA HIV vaccine antigen for safety and immunogenicity and strengthen regional scientific capacity
A post approval change order is often necessary, but innovators should plan and prepare for this pre-approval. Planning alongside outsourcing partners will help ensure that only a small-scale study is needed—not a new full clinical study
With the approval from the Central Drugs Standard Control Organisation (CDSCO), Jardiance is now the first approved therapy to improve outcomes for the full spectrum of heart failure regardless of ejection fraction
It is part of the company's CAD $30 million capital investment in the Aurora, Canada site
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