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Results For "MAA"

48 News Found

LogiPharma launches Asian focused summit, coming to Singapore in June 2023
News | April 05, 2023

LogiPharma launches Asian focused summit, coming to Singapore in June 2023

The summit encompasses multiple verticals, spanning from pharmaceuticals, biotech, life sciences, and the Healthcare sector to ensure an unbiased and comprehensive view on the future of the function.


Hutchmed completes rolling submission of NDA to USFDA for fruquintinib
Drug Approval | April 03, 2023

Hutchmed completes rolling submission of NDA to USFDA for fruquintinib

NDA supported by data from global Phase III FRESCO-2 study in the U.S., Europe, Japan and Australia along with data from Phase III FRESCO study conducted in China


Pfizer’s Elranatamab receives FDA and EMA filing acceptance
Drug Approval | February 25, 2023

Pfizer’s Elranatamab receives FDA and EMA filing acceptance

Submissions based on favorable MagnetisMM-3 trial results in patients with relapsed or refractory multiple myeloma


USFDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review
Drug Approval | February 22, 2023

USFDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review

This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency


Dr. Reddy’s completes clinical studies of its rituximab biosimilar for filing in the U.S., Europe
Drug Approval | January 21, 2023

Dr. Reddy’s completes clinical studies of its rituximab biosimilar for filing in the U.S., Europe

Following successful completion of full set of clinical studies of proposed rituximab biosimilar candidate DRL_RI, Dr. Reddy’s will now prepare to file in the United States, European Union and other regions


Valneva and Pfizer report antibody persistence data for lyme disease vaccine candidate
News | December 05, 2022

Valneva and Pfizer report antibody persistence data for lyme disease vaccine candidate

Antibody levels remained above baseline six months after completion of a three-dose (Month 0-2-6) or a two-dose (Month 0-6) vaccination schedule


EMA accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis
News | December 05, 2022

EMA accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis

Application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints


Evive enters license agreement with Acrotech Biopharma to commercialize Ryzneuta in US
News | November 24, 2022

Evive enters license agreement with Acrotech Biopharma to commercialize Ryzneuta in US

Ryzneuta is a novel dimeric G- CSF long-acting fusion protein without pegylation. The Biologics License Application (BLA) of Ryzneuta is currently under late-stage review by the US FDA for Chemotherapy-Induced Neutropenia (CIN)


We must bring logistics cost from 13% to single digit as soon as possible: Narendra Modi
Policy | September 19, 2022

We must bring logistics cost from 13% to single digit as soon as possible: Narendra Modi

The policy aspires to reduce cost of logistics in India to be comparable to global benchmarks by 2030


Thermo Fisher Scientific present new innovations to improve biopharmaceutical and proteomics workflows
News | August 30, 2022

Thermo Fisher Scientific present new innovations to improve biopharmaceutical and proteomics workflows

New mass spectrometry instrument and consumables launch during IMSC 2022