Drug Approval | September 06, 2021
Accutest enables NMPA approval for Qilu’s Abiraterone
The bioequivalence study was conducted by Accutest Research India, one of the preferred CRO players in India
The bioequivalence study was conducted by Accutest Research India, one of the preferred CRO players in India
This is Enzene Biosciences third biosimilar to be approved
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 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 vaccine will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of Covid-19 disease
New treatment options are critical, as approximately half of all people with heart failure die within five years of diagnosis. Heart failure accounts for more than one million hospitalisations a year in the US
It is the only biopharmaceutical company in India to offer all three dosage strengths of the drug (125mcg, 250mcg, and 500mcg)
This is the world’s first Covid=19 DNA vaccine developed in partnership with DBT-BIRAC
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 company has also applied to DCGI for Emergency Use Authorization (EUA) for ZyCoVD, the world's first Plasmid DNA Vaccine
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