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Results For "marketing-authorization"

183 News Found

Novavax files for approval of its Covid-19 vaccine in the UK
Biotech | October 27, 2021

Novavax files for approval of its Covid-19 vaccine in the UK

Filing marks first protein-based vaccine submitted to MHRA for authorization


Merck and Ridgeback seek EUA from U.S. FDA for molnupiravir
News | October 11, 2021

Merck and Ridgeback seek EUA from U.S. FDA for molnupiravir

If authorized, molnupiravir could be the first oral antiviral medicine for the treatment of Covid-19


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


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


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


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)


Pfizer & BioNTech submits Phase 1 data to US FDA for booster dose Covid-19
Biotech | August 17, 2021

Pfizer & BioNTech submits Phase 1 data to US FDA for booster dose Covid-19

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.


Glenmark signs agreement with SaNOtize to manufacture NONS
News | August 02, 2021

Glenmark signs agreement with SaNOtize to manufacture NONS

The Phase III clinical trial for NONS is expected to be completed by Q4 2021.