The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
NATCO’s Erdafitinib is indicated for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma harbouring susceptible FGFR3 genetic alteration
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
The facility is dedicated to breakthrough innovations in laboratory instruments that detect infectious diseases, cancer, and blood disorders
The approval follows the pivotal Phase III ARANOTE trial, which demonstrated that darolutamide plus ADT cut the risk of radiological progression or death by 46% compared to placebo plus ADT
This achievement validates global demand and catapults Wanbury into high-growth acceleration
Glucon-D maintained its leadership position with a 59% MAT market share
Nine-month revenue grew 17.5% to Rs 76,277 lakh, EBITDA climbed to Rs 15,981 lakh, and net profit reached Rs 8,200 lakh
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