Production at Biocon Biologics’ own facilities is scheduled to begin once technology transfers and regulatory approvals are finalized
NUFYMCO BLA has been approved by the USFDA
The company along with its subsidiaries has overall bed capacity of 8800+ beds as on 30th September, 2025
Under the agreement, AVT06 is licensed to enter the US market in the fourth quarter of 2026
The approval comes with 180 days of Competitive Generic Therapy (CGT) exclusivity,
The funding will support the pivotal Phase 3 clinical trial of neridronate in CRPS-1
GS-098, a first-in-class, humanized monoclonal antibody targeting the thyroid-stimulating hormone receptor, is designed to rapidly block the pathogenic activity of thyroid-stimulating autoantibodies
Imsidolimab, an IgG4 IL-36 receptor antagonist, works by inhibiting IL-36 receptor signaling, directly addressing the deficiency in the IL-36RA regulator common in GPP patients
The study also showed a clear dose-dependent trend, with the 75 mg QD group outperforming the 50 mg QD cohort
All pending litigation between Biocon Biologics, Regeneron, and Bayer will be dismissed
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