EMA starts review of sodium oxybate in alcohol dependence
Review will evaluate effectiveness in treating alcohol withdrawal syndrome and supporting abstinence, as well as measures to mitigate risk of abuse
Review will evaluate effectiveness in treating alcohol withdrawal syndrome and supporting abstinence, as well as measures to mitigate risk of abuse
The approval is based on a comprehensive package of analytical, nonclinical, and clinical data
Star Health Insurance is modernising its claims ecosystem to be future-ready
The inspection concluded with zero Form 483 observations
Prucalopride Tablets are bioequivalent to Motegrity Tablets, 1 mg and 2 mg, of Takeda Pharmaceuticals USA
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
TEVIMBRA is a uniquely designed anti-PD-1 monoclonal antibody developed by BeiGene (now BeOne Medicines)
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