Dupixent is indicated for the approximately 300,000 adults in the US with inadequately controlled COPD and an eosinophilic phenotype
Glenmark Pharmaceuticals Limited has informed that the USFDA has issued Form 483 with zero observations
New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids
The USFDA inspection focused on evaluating the facility's adherence to global regulatory requirements and best practices
The recent inspection covered both cGMP and PAI processes
Zydus receives final approval from USFDA for its NDA Zituvimeta, extended-release tablets
Over 13 million US adults aged 50-59 years have a medical condition that increases their risk of severe RSV outcomes
Approval based on results from T2NOW, one of the largest paediatric type-2 diabetes Phase III trials to date
Data support the potential of Dupixent as the first new treatment approach in more than a decade and first-ever targeted therapy for COPD
Wacker Biotech US, a wholly owned subsidiary of Wacker Chemie AG, specializes in the microbial production of pDNA
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