Teva hits major biosimilar milestones with FDA nod and regulatory filings
The US FDA has approved PONLIMSI (denosumab-adet) as a biosimilar to Prolia
The US FDA has approved PONLIMSI (denosumab-adet) as a biosimilar to Prolia
The funding will be spread over four years, with BXLS also eligible for regulatory and commercial milestones, plus royalties on worldwide sales
If approved, TEV-'749 could help address a significant unmet need in available schizophrenia treatment options by addressing the lack of viable long-acting olanzapine formulations
Duvakitug was well tolerated and safety was consistent with the induction study
The findings, from the SPACE study, paved the way for FDA approval of AJOVY for pediatric patients aged 6-17 years weighing 45 kilograms
Royalty Pharma to provide up to $500 million, including $75 million for Phase 2b funding
Under the agreement, AVT06 is licensed to enter the US market in the fourth quarter of 2026
The investigational therapy uses SteadyTeq, a proprietary copolymer technology from Medincell designed to release olanzapine steadily over time
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