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Results For "U.S"

1563 News Found

Lupin receives USFDA approval for Bumetanide Injection
Drug Approval | September 19, 2024

Lupin receives USFDA approval for Bumetanide Injection

Bumetanide Injection USP (RLD Bumex) had estimated annual sales of USD 20 million in the U.S.


Roche receives USFDA approval for Ocrevus Zunovo for treatment of progressive multiple sclerosis
Drug Approval | September 19, 2024

Roche receives USFDA approval for Ocrevus Zunovo for treatment of progressive multiple sclerosis

This approval is backed by a decade of proven safety and efficacy data of Ocrevus® IV, with over 350,000 people treated globally


FDA approves Roche’s Tecentriq Hybreza, the first and only subcutaneous anti-PD-(L) cancer immunotherapy
Drug Approval | September 16, 2024

FDA approves Roche’s Tecentriq Hybreza, the first and only subcutaneous anti-PD-(L) cancer immunotherapy

Tecentriq Hybreza provides patients and physicians with greater flexibility of treatment options while showing safety and efficacy consistent with intravenous


AGC and Medinet sign agreement for cell therapy CDMO business
News | September 12, 2024

AGC and Medinet sign agreement for cell therapy CDMO business

A new initiative to contribute to enhancing drug discovery capabilities in the field of gene and cell therapy in Japan


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


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 Pharma receives USFDA approval for daptomycin
Drug Approval | September 01, 2024

Biocon Pharma receives USFDA approval for daptomycin

The approval further adds to Biocon’s portfolio of complex drug products