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34 News Found

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


Obseva announces U.S. FDA acceptance of new drug application for linzagolix
Biotech | November 23, 2021

Obseva announces U.S. FDA acceptance of new drug application for linzagolix

Obseva announced previously that the company has entered into a partnership with Syneos Health to support commercialization of linzagolix in the US and EU


DCGI approves Enzene biosimilar Denosumab for Osteoporosis
Drug Approval | August 28, 2021

DCGI approves Enzene biosimilar Denosumab for Osteoporosis

This is Enzene Biosciences third biosimilar to be approved


Zydus Cadila receives approval from USFDA for Fulvestrant Injection
News | July 31, 2021

Zydus Cadila receives approval from USFDA for Fulvestrant Injection

The group now has 320 approvals and has so far filed over 400 ANDAs