Label updates reflect growing body of real-world evidence and regulatory confidence in the safety profile of the class of CD19- and BCMA-directed autologous CAR T cell therapies, reinforcing efforts to increase equitable access
Eylea 8 mg is the first and only anti-vascular endothelial growth factor (VEGF) treatment in the EU with treatment intervals of up to 6 months for both patients with nAMD and DME
The approval is based on a comprehensive package of analytical, nonclinical, and clinical data
The company's decision to withdraw the MAA was due to the timing of the availability of Chemistry Manufacturing and Controls
Changhua site meets international regulatory standards for global medical applications
TEVIMBRA is a uniquely designed anti-PD-1 monoclonal antibody developed by BeiGene (now BeOne Medicines)
BASF strengthens its commitment to the biopharma and pharmaceutical ingredients industries through a new investment in North America
TEMPLE, a Phase 3 multicenter, randomized, double-blind, head-to-head study, evaluated the tolerability, safety and efficacy of atogepant compared to topiramate for the preventive treatment of migraine in adult patients with a history of four or more migraine days per month
Pivotal phase III SUNMO study demonstrated an 11.5 month median progression-free survival - three times longer than R-GemOx
BRAVE study will explore the potential of omaveloxolone to address the critical unmet need of the pediatric FA population
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