This Orphan Drug Designation from the USFDA underlines the urgent medical need to develop a therapy for sickle cell disease
On segmental performance, API revenues were largely stable at Rs. 454.3 crore for Q3 FY26, down 1% YoY
Our portfolio transformation over the past few years positions us well to capitalize on improving end market conditions and deliver differentiated results in the years to come
Inspection included drug device combinations covering our recent filing in nasal sprays domain
Operating profit fell 1% in Danish kroner to DKK 127.7 billion but rose 6% at constant exchange rates
US revenue increased 43% to $12.9 billion, fueled by a 50% jump in volume, partially offset by a 7% decline in realized prices
Glucon-D maintained its leadership position with a 59% MAT market share
The program seeks to boost regulatory predictability, support construction of US-based manufacturing sites
The recommendation covers FYLREVY 14.2 mg and 18.9 mg for non-hysterectomised postmenopausal women experiencing oestrogen deficiency symptoms at least 12 months after their last menses
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