Drug Approval | June 27, 2025
Biocon Biologics receives Health Canada approval for Yesafili
The approval is based on a comprehensive package of analytical, nonclinical, and clinical data
The approval is based on a comprehensive package of analytical, nonclinical, and clinical data
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)
First and only TROP2-directed therapy approved in the US for the treatment of lung cancer
The program will start with providing bTrastuzumab to cancer patients facing treatment delays due to budget constraints
WINREVAIR significantly reduced the risk of clinical worsening events in recently diagnosed PAH patients over 70 percent of whom were on double background therapy
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
The GMP-compliant facility with automated environmental monitoring accommodates both white room and class 7 and 8 cleanroom space
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