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Results For "regulatory"

1173 News Found

Tezepelumab granted Orphan Drug Designation in the US
Biotech | October 09, 2021

Tezepelumab granted Orphan Drug Designation in the US

Tezepelumab has been granted Orphan Drug Designation (ODD) in the US by the U.S. Food and Drug Administration (FDA) for the treatment of eosinophilic esophagitis (EoE)


ASU drug manufacturing licence goes online
Policy | October 09, 2021

ASU drug manufacturing licence goes online

The applicants will only have to get their Good Manufacturing Practices certification validated every five years to retain their licence


CDSCO approves Syntellix implants
News | October 08, 2021

CDSCO approves Syntellix implants

This opens up a huge market for the company’s Magnezis implants in India


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


Health minister Mandaviya launches i-Drone for vaccine delivery
Public Health | October 05, 2021

Health minister Mandaviya launches i-Drone for vaccine delivery

This is the first time in South Asia an indigenously made drone was used to transport Covid-19 vaccines


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)


Pfizer transfers certain medicines to Mylan as part of an agreement
News | October 04, 2021

Pfizer transfers certain medicines to Mylan as part of an agreement

The consideration for the medicines in India is valued at Rs 180.48 crore


Lilly to transfer rights of two diabetes drugs to Cipla in India
Drug Approval | October 04, 2021

Lilly to transfer rights of two diabetes drugs to Cipla in India

Lilly will continue to maintain its existing operating model for the remaining portfolio of products


Takeda to collaborate with JCR Pharma to commercialise next-gen Hunter Syndrome therapy
Biotech | October 01, 2021

Takeda to collaborate with JCR Pharma to commercialise next-gen Hunter Syndrome therapy

Takeda to exclusively commercialize JR-141 outside the U.S. (except Japan and certain other Asia-Pacific countries) upon regulatory approval


Veeda Clinical Research files DRHP for Rs 831 crore IPO
News | October 01, 2021

Veeda Clinical Research files DRHP for Rs 831 crore IPO

The issue will consist of the issuance of fresh equity shares worth up to Rs 331.60 crore and an offer for sale (OFS) of Rs 500 crore by promoters and existing shareholders