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Results For "United-States"

844 News Found

Strides receives USFDA approval for Fluoxetine Tabs 60 mg
Drug Approval | September 16, 2024

Strides receives USFDA approval for Fluoxetine Tabs 60 mg

Fluoxetine Tabs 60 mg approval solidifies the company's position in the molecule by complementing the recent approval in April 2024 for Fluoxetine 10 mg and 20 mg tablets and Fluoxetine capsules


Global Bio India unveils 30 breakthrough startups: Dr. Jitendra Singh
Policy | September 14, 2024

Global Bio India unveils 30 breakthrough startups: Dr. Jitendra Singh

India's bio economy has experienced remarkable growth, skyrocketing from US $10 billion in 2014 to over $130 billion in 2024, with projections to reach $300 billion by 2030


Merck announces positive top-line results from Phase 3 trial evaluating efficacy and safety of Gardsil 9
Diagnostic Center | September 11, 2024

Merck announces positive top-line results from Phase 3 trial evaluating efficacy and safety of Gardsil 9

The trial met its primary and secondary endpoints demonstrating that administration of a 3-dose regimen of GARDASIL 9


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.


Ifinatamab Deruxtecan continues to demonstrate promising response rates for lung cancer in Phase 2 Trial
Diagnostic Center | September 09, 2024

Ifinatamab Deruxtecan continues to demonstrate promising response rates for lung cancer in Phase 2 Trial

Objective response rate of 54.8% seen with Daiichi Sankyo and Merck’s ifinatamab deruxtecan at 12 mg/kg dose in pretreated patients


Strides receive USFDA approval for Theophylline ER tablets, 300 mg and 450 mg
Drug Approval | September 06, 2024

Strides receive USFDA approval for Theophylline ER tablets, 300 mg and 450 mg

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug


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