Drug Approval | June 14, 2024
Farxiga approved in the US for the treatment of paediatric type-2 diabetes
Approval based on results from T2NOW, one of the largest paediatric type-2 diabetes Phase III trials to date
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
With this, for all our USFDA facilities, EIRs are in place
Submission based on results from pivotal phase III trial showing all primary endpoints met
SELARSDI is approved for both adult and pediatric indications and is the second biosimilar approved under the strategic partnership between Alvotech and Teva
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This facility manufactures APIs & formulations of oncology and non-oncology products.
Approximately half of all patients with metastatic breast cancer (mBC) express low levels of HER2
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The regulator carried out a routine current Good Manufacturing Practices (cGMP) inspection from March 28 to April 4.
Application based on results from the TROPION-Breast01 Phase III trial
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