News | June 26, 2025
Philogen withdraws marketing authorization application for Nidlegy in EU
The company's decision to withdraw the MAA was due to the timing of the availability of Chemistry Manufacturing and Controls
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
Changhua site meets international regulatory standards for global medical applications
First and only TROP2-directed therapy approved in the US for the treatment of lung cancer
Pivotal phase III SUNMO study demonstrated an 11.5 month median progression-free survival - three times longer than R-GemOx
QuantumNexis will serve as the innovative engine for HCTI's recurring revenue business lines
The company received seven observations in the Form-483
The GMP-compliant facility with automated environmental monitoring accommodates both white room and class 7 and 8 cleanroom space
The company received one observation in the Form-483
The inspection concluded successfully, with the facility found to be in compliance with the required regulations
Subscribe To Our Newsletter & Stay Updated
