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Results For "authorization"

327 News Found

Cadila Healthcare receives permission to conduct Phase III trials for two-dose ZyCoV-D
News | October 06, 2021

Cadila Healthcare receives permission to conduct Phase III trials for two-dose ZyCoV-D

The company has already received the emergency use authorization (EUA) from the Drug Controller General of India (DCGI) for ZyCoV-D to be administered in three doses on August 20


AstraZeneca requests Emergency Use Authorisation for drug to prevent Covid
Biotech | October 05, 2021

AstraZeneca requests Emergency Use Authorisation for drug to prevent Covid

The filing includes data from PROVENT Phase III trial showing 77% reduction in risk of developing symptomatic Covid-19 with a long-acting antibody combination (non-vaccine)


Tavneos (avacopan) approved for ANCA associated vasculitis in Japan
Drug Approval | September 28, 2021

Tavneos (avacopan) approved for ANCA associated vasculitis in Japan

It is the first orally administered therapy for the treatment of two types of ANCA-associated vasculitis approved in Japan


Aurobindo subsidiary submits MAA for oncology biosimilar
Biotech | September 23, 2021

Aurobindo subsidiary submits MAA for oncology biosimilar

CuraTeQ Biologics is on track for filing a second oncology biosimilar


HUTCHMED initiates a Japan bridging study to Support Surufatinib
Biotech | September 21, 2021

HUTCHMED initiates a Japan bridging study to Support Surufatinib

Surufatinib is the third potential new medicine discovered by the company to enter into clinical development in Japan


Pfizer and BioNTech’s Covid-19 vaccine safe for children aged 5 to 11: study
Biotech | September 21, 2021

Pfizer and BioNTech’s Covid-19 vaccine safe for children aged 5 to 11: study

In participants 5 to 11 years of age, the vaccine was safe, well-tolerated and showed robust neutralising antibody responses. Results in children under 5 years of age are expected as soon as later this year


Canada approves Moderna’s Covid-19 vaccine
Drug Approval | September 17, 2021

Canada approves Moderna’s Covid-19 vaccine

In the final analysis of Phase 3 COVE study data, SPIKEVAX showed 93% efficacy, with the efficacy remaining durable through six months after the administration of the second dose


US FDA grants Emergency Use Authorisation for Covid-19 pooled samples
Biotech | September 14, 2021

US FDA grants Emergency Use Authorisation for Covid-19 pooled samples

Visby Medical’s instrument-free PCR test to detect the SARS-CoV-2 virus can now be used to pool up to five patient samples using a single test


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