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Results For "New-Drug-Application"

339 News Found

Sentynl Therapeutics receives USFDA acceptance and priority review of new drug application for CUTX-101 product candidate for treatment of Menkes disease
Drug Approval | January 07, 2025

Sentynl Therapeutics receives USFDA acceptance and priority review of new drug application for CUTX-101 product candidate for treatment of Menkes disease

Menkes disease is a rare X-linked recessive pediatric disease caused by gene mutations of the copper transporter ATP7A


Bayer submits supplemental new drug application to USFDA seeking expanded indication for NUBEQA
Drug Approval | September 29, 2024

Bayer submits supplemental new drug application to USFDA seeking expanded indication for NUBEQA

NUBEQA is currently indicated for the treatment of adult patients with mHSPC in combination with docetaxel and for non-metastatic castration-resistant prostate cancer (nmCRPC)


Zydus’ new drug application of Desidustat tablets accepted by China Medical System Holdings
Drug Approval | April 23, 2024

Zydus’ new drug application of Desidustat tablets accepted by China Medical System Holdings

Desidustat, administered orally is a novel, oral Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitor (HIF-PHI) for treating anaemia in Chronic Kidney Disease (CKD) patients


Sun Pharma gets USFDA filing acceptance of new drug application for Deuruxolitinib
Drug Approval | October 09, 2023

Sun Pharma gets USFDA filing acceptance of new drug application for Deuruxolitinib

The NDA filing for deuruxolitinib with the U.S. FDA is based on two pivotal Phase III trials


Astellas submits new drug application for Zolbetuximab in Japan
News | June 13, 2023

Astellas submits new drug application for Zolbetuximab in Japan

Ministry of Health, Labour and Welfare to evaluate zolbetuximab as treatment option for patients with advanced gastric and gastroesophageal cancers


USFDA lifts clinical hold on Phase 3 investigational new drug application for MaaT013
Drug Approval | April 24, 2023

USFDA lifts clinical hold on Phase 3 investigational new drug application for MaaT013

This is the first time the Agency has authorized the Phase 3 clinical evaluation in the U.S of a microbiota-based live biotherapeutic based on a pooling technology


FDA approves Pfizer's supplemental new drug application for CIBINQO
Drug Approval | February 14, 2023

FDA approves Pfizer's supplemental new drug application for CIBINQO

Label expansion for CIBINQO provides new systemic oral option for adolescents (12 to <18 years) with moderate-to-severe atopic dermatitis


US FDA accepts supplemental new drug application for Jardiance for adults with chronic kidney disease
News | January 23, 2023

US FDA accepts supplemental new drug application for Jardiance for adults with chronic kidney disease

The supplemental New Drug Application is based on results from the landmark EMPA-KIDNEY phase III trial


Pfizer submits new drug application to the U.S. FDA for Paxlovid
Drug Approval | July 03, 2022

Pfizer submits new drug application to the U.S. FDA for Paxlovid

Submission seeks approval for the treatment of COVID-19 in both vaccinated and unvaccinated individuals at high risk


Menarini Group and Radius Health submit new drug application to the USFDA for Elacestrant
Drug Approval | June 23, 2022

Menarini Group and Radius Health submit new drug application to the USFDA for Elacestrant

Intended for potential treatment of ER+/HER2- advanced or metastatic breast cancer patients