Drug Approval | August 25, 2024
BI Sky Global successfully completes FDA MoCRA registration
MoCRA mandates that all facilities involved in the manufacturing and processing of cosmetic products for sale in the United States
MoCRA mandates that all facilities involved in the manufacturing and processing of cosmetic products for sale in the United States
Approval based on MIRACLE Phase III trial demonstrating a significant and clinically meaningful reduction in asthma exacerbations and improvement in asthma symptom control
The JV will establish a state-of-the-art manufacturing facility to manufacture fermented animal free protein to cater to the global markets
New Chair brings extensive experience in global pharmaceutical and biotechnology leadership, healthcare innovation, and strategic drug development
The updated COVID-19 vaccine is tailored to the KP.2 strain of the SARS-CoV-2 Omicron JN.1 lineage and is recommended for individuals 6 months of age and older
Roche confirms that its cobas MPXV test, as well as the LightMix research use only kits, detect the latest mpox virus variants
Sun Pharma has obtained rights from MSD to develop, manufacture and commercialise Tedizolid Phosphate in India
Novartis has option to acquire two future development-ready programs to augment its renal portfolio, a strategic area of focus for the company
Pegfilgrastim is a Pegylated form of the recombinant human granulocyte colony-stimulating factor (G-CSF) analogue Filgrastim
USFDA has determined that the inspection classification of this facility is "No Action Indicated" (NAI) with zero 483 observation
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