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Results For "FDA"

2187 News Found

Zydus Lifesciences announces completion of Phase II(a) clinical trial of Usnoflast
Clinical Trials | September 11, 2024

Zydus Lifesciences announces completion of Phase II(a) clinical trial of Usnoflast

ALS patients experience neuroinflammation and rapid neurodegeneration


Briefs: Ami Organics and Dr. Reddy’s Laboratories
Drug Approval | September 09, 2024

Briefs: Ami Organics and Dr. Reddy’s Laboratories

Ami informs that PMDA Japan has issued Inspection Result Report declaring the Sachin facility as a Good Manufacturing Practices (GMP) compliant.


Sun Pharma and Moebius Medical granted FTD to MM-II for treatment of osteoarthritis knee pain
Drug Approval | September 06, 2024

Sun Pharma and Moebius Medical granted FTD to MM-II for treatment of osteoarthritis knee pain

This Fast Track Designation will enable FDA to review MM-II in an expedited manner, is an important milestone in the development of MM-II


NATCO Pharma (Canada) announces US$ 8 million investment in eGenesis
News | September 04, 2024

NATCO Pharma (Canada) announces US$ 8 million investment in eGenesis

eGenesis is pioneering a genome engineering-based approach in the development of safe and effective transplantable organs to end the global organ shortage


Lupin launches Mirabegron ER tablets in US
Drug Approval | September 04, 2024

Lupin launches Mirabegron ER tablets in US

Mirabegron Extended-Release Tablets, 50 mg is a generic equivalent of Myrbetriq® Extended-Release Tablets, 50 mg of Astellas Pharma Global Development


Lupin launches Doxorubicin Hydrochloride Liposome Injection in US
Drug Approval | September 03, 2024

Lupin launches Doxorubicin Hydrochloride Liposome Injection in US

ForDoz Pharma Corporation, USA (ForDoz) received an approval for its ANDA from the USFDA


Biocon Biologics secures market entry for Bmab 1200 in Europe, UK, Canada, and Japan
News | August 30, 2024

Biocon Biologics secures market entry for Bmab 1200 in Europe, UK, Canada, and Japan

Biocon Biologics earlier announced a settlement agreement in the United States for a Bmab 1200 launch no later than February 22, 2025


Bayer starts Phase III trial in non-small cell lung cancer
Clinical Trials | August 30, 2024

Bayer starts Phase III trial in non-small cell lung cancer

First patient enrolled in the Phase III SOHO-02 trial of investigational agent BAY 2927088 in treatment-naïve patients with advanced NSCLC with HER2-activating mutations


Shilpa Medicare announces positive outcome of Phase 3 studies of NorUDCA
Clinical Trials | August 26, 2024

Shilpa Medicare announces positive outcome of Phase 3 studies of NorUDCA

Nor UDCA is likely to be a first-in-class treatment option for NAFLD in India


Ashland Rad-Sure indicators approved by AABB Standards-Compliant product program
News | August 21, 2024

Ashland Rad-Sure indicators approved by AABB Standards-Compliant product program

Rad-Sure blood irradiation indicators are FDA 510 (k) cleared medical devices that offer positive visual verification of irradiation at the minimum specified dose