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Results For "MAA"

46 News Found

Henlius' Serplulimab granted Orphan-Drug Designation for Small Cell Lung Cancer
Biotech | April 08, 2022

Henlius' Serplulimab granted Orphan-Drug Designation for Small Cell Lung Cancer

The company plans to file its NDA in China and MAA in the EU in 2022, making Hansizhuang potentially to be the world's first PD-1 inhibitor for the first-line treatment of SCLC


BioPharma’s Herceptin biosimilar Phase 3 results positive
Biotech | March 12, 2022

BioPharma’s Herceptin biosimilar Phase 3 results positive

The study met its primary endpoint and showed equivalent efficacy and a comparable safety profile


AstraZeneca flags off ‘AZ Forest’ a mass sapling plantation campaign in Bengaluru
Sustainability | March 07, 2022

AstraZeneca flags off ‘AZ Forest’ a mass sapling plantation campaign in Bengaluru

Commits to plant 5000 trees in phase 1 with its partner SankalpTaru Foundation


VBI’s 3-antigen Hepatitis B vaccine gets CHMP nod
Biotech | February 27, 2022

VBI’s 3-antigen Hepatitis B vaccine gets CHMP nod

If approved, PreHevbri will be the only approved 3-antigen hepatitis B vaccine for adults in the E.U.


Prestige BioPharma’s facility receives EU-GMP certification
Biotech | February 22, 2022

Prestige BioPharma’s facility receives EU-GMP certification

The facility will manufacture its Herceptin biosimilar, Tuznue


Nirsevimab EMA regulatory submission accepted under accelerated assessment
Biotech | February 17, 2022

Nirsevimab EMA regulatory submission accepted under accelerated assessment

Nirsevimab is the first investigational long-acting antibody designed to protect all infants for the respiratory syncytial virus season with a single dose


Ascent Meditech chalks out ambitious growth plans: Rajiv Mistry, Founder & Managing Director, Ascent Group
interviews | February 03, 2022

Ascent Meditech chalks out ambitious growth plans: Rajiv Mistry, Founder & Managing Director, Ascent Group

Ascent Meditech has set benchmarks in introducing pain management products in India. The company has embarked on a new marketing campaign as it plans to enter new markets. Rajiv Mistry, Founder & Managing Director, Ascent Group shares his perspective with Thomas C Thottathil on the road ahead for the company and industry


Veristat supported marketing applications for 12 % of all FDA Novel Drug Approvals in 2021
News | January 12, 2022

Veristat supported marketing applications for 12 % of all FDA Novel Drug Approvals in 2021

This surpasses the number of approvals supported in 2020


U.S. FDA accepts Bristol Myers Squibb’s application for Deucravacitinib
Biotech | November 30, 2021

U.S. FDA accepts Bristol Myers Squibb’s application for Deucravacitinib

Applications supported by positive results from the pivotal Phase 3 POETYK-PSO clinical trial program demonstrating superior efficacy of deucravacitinib over Otezla (apremilast)