The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories
Aurobindo will respond to the US FDA within the stipulated timelines
Good momentum in commercial CDMO business
If approved, KEYTRUDA would be the first immunotherapy for the first-line treatment of HER2-positive advanced gastric or GEJ cancer in tumors expressing PD-L1 (CPS ?1) in the EU
The Long-term Safety Trial was approved to be conducted by China National Medical Products Administration (NMPA) on 18 April 2023
Mage Biologics to develop a monoclonal antibody targeting ulcerative colitis
CMOs showed an increasing reluctance to take on debt in 2022
Shivalik Rasayan Limited has issued LOA to Medicamen Biotech to use its DMF grade Bortezomib API for formulation of Bortezomib injection 3.5mg/ vial
OncoVeryx-F, a proprietary test developed by PredOmix, is set to transform early-stage cancer detection
Moist wound dressing for chronic wound treatment now available in Germany
Subscribe To Our Newsletter & Stay Updated
