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Results For "2023"

1167 News Found

GSK receives USFDA file acceptance for Jemperli plus chemotherapy for the treatment of endometrial cancer
Drug Approval | June 12, 2023

GSK receives USFDA file acceptance for Jemperli plus chemotherapy for the treatment of endometrial cancer

Application being reviewed under the FDA Project Orbis framework, which enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore and United Kingdom health authorities


Novartis unveils results of survey on chronic myeloid leukemia
News | June 12, 2023

Novartis unveils results of survey on chronic myeloid leukemia

Survey of Unmet Needs in chronic myeloid leukemia (CML SUN) data signal need for amplified patient voice during treatment discussions that balance quality of life (QoL), efficacy, and tolerability goals across all lines of therapy


Novartis to acquire Chinook Therapeutics for US$ 3.2 bn
News | June 12, 2023

Novartis to acquire Chinook Therapeutics for US$ 3.2 bn

Chinook Therapeutics is a clinical-stage biopharmaceutical company with two high-value, late-stage assets in development for IgA nephropathy (IgAN), a rare, progressive chronic kidney disease


Indoco's Baddi facility receives EUGMP certification from Health Authority of Germany
Drug Approval | June 10, 2023

Indoco's Baddi facility receives EUGMP certification from Health Authority of Germany

The EU certification will support supplies of drug products registered in Europe, from this manufacturing site


Zydus receives final approval from USFDA for Esomeprazole Magnesium
Drug Approval | June 09, 2023

Zydus receives final approval from USFDA for Esomeprazole Magnesium

Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg and 40 mg had annual sales of USD 42 mn in the United States (IQVIA MAT April 2023)


Lantern Pharma leverages AI platform to develop breakthrough ADCs with Bielefeld University
Digitisation | June 09, 2023

Lantern Pharma leverages AI platform to develop breakthrough ADCs with Bielefeld University

Lantern is receiving an exclusive and worldwide option to license intellectual property from Bielefeld University related to the collaboration and IP generated from the collaboration


Croda breaks ground on lipid manufacturing facility in Pennsylvania
News | June 09, 2023

Croda breaks ground on lipid manufacturing facility in Pennsylvania

Construction will begin this year with the new capacity anticipated by 2025


Zydus receives final approval from the USFDA for Tadalafil Tablets USP
Drug Approval | June 08, 2023

Zydus receives final approval from the USFDA for Tadalafil Tablets USP

Tadalafil Tablets USP, 20 mg had annual sales of USD 61 mn in the United States (IQVIA MAT April 2023)


European Commission authorises GSK’s Arexvy for older adults
Drug Approval | June 08, 2023

European Commission authorises GSK’s Arexvy for older adults

Authorisation will help protect adults 60 years of age and older in 30 European countries* from RSV disease for the first time


Mixed prospects for Merck lawsuit against US federal government, says GlobalData
News | June 07, 2023

Mixed prospects for Merck lawsuit against US federal government, says GlobalData

The judicial response to industry lawsuits on drug pricing regulations have been mixed in the past