Approval based on MIRACLE Phase III trial demonstrating a significant and clinically meaningful reduction in asthma exacerbations and improvement in asthma symptom control
USFDA has determined that the inspection classification of this facility is "No Action Indicated" (NAI) with zero 483 observation
This product will be manufactured by Indoco at its manufacturing facility located at L-14, Verna Industrial Area, Verna, Goa in India
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
In a Phase 3 trial, Pfizer and BioNTech’s combination vaccine candidate against influenza and COVID-19 met one of its two primary immunogenicity objectives
These results add to the growing body of evidence indicating a single dose of ABRYSVO provides strong immune protection against outcomes caused by RSV
Third approval in China for AstraZeneca and Daiichi Sankyo’s Enhertu in less than two years
For the 2024 outlook, sales growth is now expected to be 22-28% at CER
EBITDA for Q1 FY25 is at Rs. 100 crore compared to Rs. 32 crore in the previous year
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