FDA nod to YUVIWEL, first once-weekly treatment for kids with achondroplasia
Achondroplasia, a rare genetic disorder, causes skeletal dysplasia and often increases the risk of muscular, neurological, and cardiorespiratory complications
Achondroplasia, a rare genetic disorder, causes skeletal dysplasia and often increases the risk of muscular, neurological, and cardiorespiratory complications
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
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