Lupin receives EIR from FDA for its Goa facility
The EIR was issued following an inspection of the facility from November 10 to November 21, 2025
The EIR was issued following an inspection of the facility from November 10 to November 21, 2025
Zongertinib is setting a new standard as the first targeted therapy for treatment naïve patients with HER2-mutant advanced non-small cell lung cancer with demonstrated efficacy
BRAFTOVI in combination with cetuximab and mFOLFOX6 had previously received accelerated approval in December 2024 based on objective response rate (ORR) results
The innovative eyedrop targets inflammation and pain following ocular surgery
CagriSema produced a 23% weight loss at 84 weeks, versus 25.5% for tirzepatide
In 2025, over 1 million patients accessed Lilly treatments through LillyDirect
If approved, DTX401 would be the first treatment to address the disease at its root cause
The decision follows compelling data from the AMPLIFY Phase III trial, demonstrating that 77% of patients receiving the Calquence-venetoclax combination were progression-free at three years
The NDA filing is supported by results from the phase III evERA Breast Cancer study
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