Review will evaluate effectiveness in treating alcohol withdrawal syndrome and supporting abstinence, as well as measures to mitigate risk of abuse
The inspection concluded with zero Form 483 observations
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)
This collaboration ensures that patients receive comprehensive care, including emotional and psychological support throughout their fertility journey
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
This is the second and final phase of the overall capacity addition of ?195 kL which was under construction at Unit IV Bidar facility
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