Biopharma | December 16, 2025
FDA accepts Sentynl Therapeutics CUTX-101 NDA resubmission
If approved, CUTX-101 will be the first and only FDA approved treatment available for Menkes disease
If approved, CUTX-101 will be the first and only FDA approved treatment available for Menkes disease
Qfitlia is the first antithrombin (AT)-lowering therapy approved for routine prophylaxis in hemophilia
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 Phase-2b study is a randomized, double-blind, placebo-controlled trial that will enroll approximately 195 patients across 35 sites in the USA
The Phase 3 HER2CLIMB-05 trial showed a 35.9% reduction in risk for patients treated with TUKYSA
The investigational therapy uses SteadyTeq, a proprietary copolymer technology from Medincell designed to release olanzapine steadily over time
Columvi combined with gemcitabine and oxaliplatin dramatically extends survival in people with relapsed or refractory diffuse large B-cell lymphoma
The study met its primary endpoint and all 11 secondary efficacy endpoints
While Merck can appeal, Halozyme said it expects the order to hold
MRI is particularly valuable in pediatric care due to its non-invasive nature
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