Drug Approval | July 26, 2024
USFDA inspects Gland Pharma’s Dundigal facility
The inspection was concluded with two 483 observations
The inspection was concluded with two 483 observations
A one-time dose of DURVEQTIX has reduced bleeds post-treatment compared to standard of care with a median annualized bleed rate (ABR) of zero bleeds (range 0 to 9.9)
This strategic move aims to make Cupid's high-quality products more accessible to consumers nationwide
Leqselvi delivered statistically significant efficacy across two Phase 3 clinical trials
EBITDA grew by 31% YoY with EBITDA margin of 11%, a YoY improvement of over 170bps vs. Q1FY24
Laurus Labs has reported total income of Rs. 1,197.42 crores during the period ended June 30, 2024
The discussion at the fourth session was centered on the fusion of academic rigor and industrial pragmatism as a key to pioneering solutions for sustainable and prosperous future
The product is bioequivalent and therapeutically equivalent to the reference listed drug
Shilpa Biologicals has developed high concentration adalimumab (100 mg/mL)
The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ - II, India
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