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1079 News Found

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


World’s first intra-nasal vaccine for COVID developed by India has got approval from CDSCO
News | December 02, 2022

World’s first intra-nasal vaccine for COVID developed by India has got approval from CDSCO

Phase-III trials were conducted for safety, and immunogenicity in around 3,100 subjects, in 14 trial sites across India (supported by BIRAC)


Lupin's subsidiary MedQuimica acquires rights to nine brands from Bausch Health
News | November 29, 2022

Lupin's subsidiary MedQuimica acquires rights to nine brands from Bausch Health

The acquired brands are well established and recognized among doctors and other members of the medical fraternity in Brazil for their reliability, safety, and trustworthiness


Japan approves ENHERTU for treatment of adult patients with HER2 positive unresectable breast cancer
Drug Approval | November 27, 2022

Japan approves ENHERTU for treatment of adult patients with HER2 positive unresectable breast cancer

Approval broadens indication for ENHERTU to earlier use in metastatic breast cancer and requirement for confirmatory phase 3 trial


USFDA grants priority review of BLA for dengue vaccine TAK-003
Drug Approval | November 23, 2022

USFDA grants priority review of BLA for dengue vaccine TAK-003

If approved, TAK-003 has the potential to become an important dengue prevention option for healthcare providers


Pfizer and BioNTech receive positive CHMP opinion for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster
Drug Approval | November 11, 2022

Pfizer and BioNTech receive positive CHMP opinion for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster

The European Commission will review the CHMP recommendation and is expected to make a final decision soon.


YS Biopharma announces USFDA clearance of IND Application for PIKA COVID-19 vaccine
Drug Approval | November 11, 2022

YS Biopharma announces USFDA clearance of IND Application for PIKA COVID-19 vaccine

PIKA COVID-19 vaccine is currently in Phase 3, multi-country, multi-center clinical trial conducted at Southeast Asian and Middle East countries.


Solvay partners with Ostium in single-use surgical instruments material recycling
Sustainability | November 09, 2022

Solvay partners with Ostium in single-use surgical instruments material recycling

Value chain collaboration aims to foster a circular ecosystem and reduce the carbon footprint of single-use surgical instruments molded in Ixef PARA.


Astec LifeSciences plan Capex of Rs. 300 - 350 Cr
News | November 08, 2022

Astec LifeSciences plan Capex of Rs. 300 - 350 Cr

R&D center would be doing a lot of new product generation projects, process optimization, scale-up and product life cycle management work, full synthetic labs, the kilo labs, the process safety labs, and the population lab


Zydus Announces New Data Presentations at The Liver Meeting 2022
News | November 04, 2022

Zydus Announces New Data Presentations at The Liver Meeting 2022

Saroglitazar Mg is an investigational compound in the USA/EU, undergoing Phase 2b/3 clinical trials in patients with Primary Biliary Cholangitis and Phase 2b in patients with Non- alcoholic Steatohepatitis