Lupin receives 7 observations from USFDA for Goa manufacturing facility
Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe
Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe
AVT03 is a biosimilar of Amgen's Prolia (denosumab 60 mg/mL) and Xgeva (denosumab 70 mg/mL), which are used to treat various bone conditions
Desai is currently serving the company as Group Finance Controller
Winlevi is authorized in EU for the treatment of acne vulgaris
The approvals target adult MIBC patients who are ineligible for cisplatin-based chemotherapy
The study successfully met its primary endpoint, demonstrating similar rates of viral suppression for DOR/ISL compared to Biktarvy at 48 weeks
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