Biotech | August 31, 2021
US FDA grants Lantern Pharma additional Orphan Drug tag for LP-184
The drug is also intended for the treatment of glioblastoma multiforme
The drug is also intended for the treatment of glioblastoma multiforme
It is estimated that over 11,000 children across Europe, Middle East, and Africa are affected by achondroplasia and could be eligible for treatment with Voxzogo
The product will be available in 500 mg/2.5 mL and 1 g/5 mL vials
The submission to the US FDA has been initiated and they intend to file these data with the European Medicines Agency and other regulatory bodies in the coming weeks
The data suggest that a booster dose given within 6 to 12 months after the second dose may help maintain a high level of protection against COVID-19.
The approval is based on a multi-centre, single-arm, open-label pivotal clinical trial
If approved it will bring a second source of MMR vaccine to the US market
The company has also applied to DCGI for Emergency Use Authorization (EUA) for ZyCoVD, the world's first Plasmid DNA Vaccine
A veteran in cell therapy and oncology commercialisation
Pegfilgrastim has estimated annual sales of USD 3.66 billion in the U.S. (IQVIA MAT December 2020).
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