Approval based on FLAURA2 results which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly 9 months vs. standard of care
Dr. Reddy's Laboratories gets Form 483 from USFDA with 4 observations for API facility
Before joining Gland, Loomba was associated with Shalina Labs, Harman Finochem, Aurobindo Pharma, Sun Pharmaceuticals and Ranabaxy Laboratories.
Granules India received approval from Brazilian Health Regulatory Agency ANVISA
NDA supported by data from global Phase III FRESCO-2 study in the U.S., Europe, Japan and Australia along with data from Phase III FRESCO study conducted in China
The approved product is indicated for the treatment of adult patients with Multiple myeloma, in combination with Dexamethasone
With this QIP placement, the Dhanuka group, which took over the company in 2018, is also meeting its mandatory obligation to dilute 15 percent stake in the company by March 2023
Formulation revenue decreased by 7.6% YoY to Rs. 4,770 crore whereas in Q2 FY23, API business posted a growth of 24.2% YoY with revenue of Rs. 969.4 crore
The booster vaccination trial is still ongoing and further data will provide more information around safety and efficacy.
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