These digital initiatives are expected to enhance the accessibility and efficiency of drug safety monitoring and standards compliance
This is in partnership with Mepro Pharmaceuticals which have successfully developed and commercialised the Albendazole Chewable formulation
Application based on the Transcend FL trial in which Breyanzi showed deep and durable responses and a consistent and well-established safety profile
Based on AEGEAN Phase III trial results which showed Imfinzi-based regimen reduced the risk of recurrence, progression or death by 32% vs. neoadjuvant chemotherapy alone
The clinical trial will be conducted at 19 sites with 10,335 participants across India
These results add to the growing body of evidence indicating a single dose of ABRYSVO provides strong immune protection against outcomes caused by RSV
The inspection was concluded with zero observations
The EIR was issued post the last inspection of the facility conducted from May 6-10, 2024 which concluded with zero FDA 483 observations
Observes no adverse impact of non-nutritive sweetener (NNS) - sucralose on glycemic markers
The successful completion of the global Phase 3 trials paves the way to obtain marketing approval in the U.S. and EU
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