The inspection concluded with the issuance of a form 483 with five observations
The Shasta system and Shasta Whole-Genome Amplification (WGA) Kit dramatically increase throughput for WGA by processing up to 1,500 cells per run
The samples of both products mentioned in the CDSCO list are spurious and not manufactured by Alkem
At 24 months, data from the Phase 1 exPDite trial continue to show a favorable safety profile in all 12 participants in the trial’s high and low dose cohorts
These clinical studies support the interchangeability of adalimumab-fkjp at low-concentration with high-concentration adalimumab and ustekinumab biosimilarity
The exclusive hospital will help address health complexities concerning women and children, specializing in high-end obstetrics, comprehensive gynecological, neonatal & pediatric care
Based out of Boston, Vivek will build on the foundation created by Vaidheesh, and will help build a stronger customer connect and further drive global expansion of the platform
A multi-disciplinary team of senior physicians opted to use Zidebactam/Cefepime under compassionate use
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