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
The company's decision to withdraw the MAA was due to the timing of the availability of Chemistry Manufacturing and Controls
The NovaSeq X system features Illumina's cutting-edge XLEAP-SBS chemistry, offering unmatched throughput, accuracy, and sustainability
TEVIMBRA is a uniquely designed anti-PD-1 monoclonal antibody developed by BeiGene (now BeOne Medicines)
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
Enflosina is a long-acting monoclonal antibody that provides direct protection for up to 5 months
The acquisition sets up the foundation for a central hub of GMP value-added services and greater access to new customers in the rapidly growing Biopharma market
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