A novel second-generation approach to achieve a safe, durable, and stable transgene expression to overcome the challenges of factor VIII replacement therapies
50 µg dose approved for all adults over 50 years of age and immunocompromised adults over 18 years of age
The company plans to launch the product immediately
The studies demonstrate a standardized strategy to extend mechanistic modeling and systems pharmacology into drug safety and mode of action assessments that has relevance for drug development and a variety of other contexts
Dr. Bibikova is an international leader with over 25 years of experience in genomics industry
The breakthrough approval expands the existing indication of Jardiance to include adults with heart failure with preserved ejection fraction (HFpEF), an underserved patient population that previously had no approved therapies in Europe
First of three Amneal biosimilars expected for U.S. approval and launch in 2022
AMX0035 is an investigational therapy for the treatment of amyotrophic lateral sclerosis (ALS).
Spikevax has received approval by regulators in more than 70 countries, including Canada, Japan, the European Union, the UK, Israel
Glenmark’s current portfolio consists of 173 products authorized for distribution in the U.S. marketplace and 46 ANDA’s pending approval with the U.S. FDA
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