Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 29

Results For "authorization"

309 News Found

Granules India recalls one batch of Naproxen Sodium 220mg tablets
News | September 13, 2021

Granules India recalls one batch of Naproxen Sodium 220mg tablets

One batch has 11.4 million units of Naproxen tablets out of which 0.9 million units that were released into the market were recalled


DGCI approves Hetero’s Tocilizumab
Drug Approval | September 06, 2021

DGCI approves Hetero’s Tocilizumab

Hetero’s drug is a biosimilar version of Roche’s Actemra/RoActemra and will be available at the end of this month


Accutest enables NMPA approval for Qilu’s Abiraterone
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


DCGI approves Enzene biosimilar Denosumab for Osteoporosis
Drug Approval | August 28, 2021

DCGI approves Enzene biosimilar Denosumab for Osteoporosis

This is Enzene Biosciences third biosimilar to be approved


European Commission grants market authorisation for BioMarin’s Voxzogo
Biotech | August 28, 2021

European Commission grants market authorisation for BioMarin’s Voxzogo

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


Pfizer and BioNTech initiate rolling submission for Comirnaty booster dose
Drug Approval | August 26, 2021

Pfizer and BioNTech initiate rolling submission for Comirnaty booster dose

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


USFDA grants full approval for Pfizer-BioNTech Covid-19 vaccine
News | August 23, 2021

USFDA grants full approval for Pfizer-BioNTech Covid-19 vaccine

The vaccine will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of Covid-19 disease


US FDA approves Jardiance to treat adults living with heart failure with a reduced ejection fraction
Drug Approval | August 20, 2021

US FDA approves Jardiance to treat adults living with heart failure with a reduced ejection fraction

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


Enzene Biosciences obtains DCGI approval for Romiplostim biosimilar
Biotech | August 20, 2021

Enzene Biosciences obtains DCGI approval for Romiplostim biosimilar

It is the only biopharmaceutical company in India to offer all three dosage strengths of the drug (125mcg, 250mcg, and 500mcg)


Zydus Cadila receives Emergency Use Authorisation for 3-dose ZyCoV-D vaccine
Biotech | August 20, 2021

Zydus Cadila receives Emergency Use Authorisation for 3-dose ZyCoV-D vaccine

This is the world’s first Covid=19 DNA vaccine developed in partnership with DBT-BIRAC