The approval, following a positive recommendation from the European Medicines Agency’s CHMP, makes the vaccine valid across all 27 EU member states
IgAN is a rare, progressive kidney disease driven by abnormal IgA immune complexes that deposit in the kidneys
The newly formed SAB will provide strategic direction across research, clinical development, and regulatory pathways
By prioritising absolute compliance, leveraging the power of digital tools, and aligning with government policies, the sector is locking in its future leadership
Shift from approvals to digital intimation via NSWS portal aims to cut timelines and boost innovation in early-stage drug development
PMDA is regarded among the most stringent regulatory bodies globally
The litigation involved multiple civil lawsuits alleging anti-competitive practices and violations of federal
Analysts expect modest revenue growth but pressure on profitability in the March quarter
The approved product is a generic version of Ravicti, originally developed and marketed by Horizon Therapeutics
The study was conducted by PwC India in line with ISO 14040 and ISO 14044 protocols
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