News | December 17, 2025
AstraZeneca wins EU nod for self-administered lupus drug Saphnelo
Convenient subcutaneous option has potential to reach more patients with same clinical benefits as Saphnelo IV infusion
Convenient subcutaneous option has potential to reach more patients with same clinical benefits as Saphnelo IV infusion
Ryght AI tackles these hurdles with its AI Site Twin platform
The reform is set to modernise how medicines are developed, authorised, and made available across the EU
The drug is currently being evaluated in two fully recruited global Phase 3 studies for progressive and tophaceous gout, with results expected in 2026.
Clinical trial enrollment has long been a bottleneck in drug development
All pending litigation between Biocon Biologics, Regeneron, and Bayer will be dismissed
Updated results from the EMBER-3 study showed that the drug -- Inluriyo (imlunestrant) -- as a standalone treatment cut the risk of progression or death by 38%
The positive CHMP opinion is supported by results from the Phase III QUASAR trial
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb
The cobas Mass Spec solution Ionify reagent portfolio now covers therapeutic drug monitoring for immunosuppressants and antibiotics
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