Urtė has previously worked as a Healthcare Reporter at GlobalData Media, primarily writing for Clinical Trials Arena. She mostly focused on clinical trial data management, strategy, and regulatory updates as well as clinical trial data readouts and exclusive interviews with C-level pharma and biotech executives. Urtė holds an MA in International Journalism from City, University of London.
Latest from Urtė Fultinavičiūtė
Lupin announced US FDA approval for its Armlupeg (pegfilgrastim-unne) biosimilar and a licensing deal with Valorum in a span of a few days.
Zydus inks a new 505(b)(2) oncology deal, taking over the commercialization of RK Pharma’s undisclosed sterile injectable in the US.
Prestige Biopharma has picked Biosidus to manufacture and export its Tuznue biosimilar rival to Herceptin across four Latin American countries.
The US FDA delivered its promise to publish product-specific guidances in November, after two late batches earlier this year. Third time might have been a charm, but it remains to be seen if the December batch will be the fourth time guaranteed.
Generics Bulletin reviews global regulatory developments across the world.
Amphastar sees two highly likely launches in 2026, with one of them significantly contributing to next year's revenues. However, both generics are yet to be approved by the US FDA.