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Results For "USFDA"

1135 News Found

FDA approves Medtronic’s new Simplera Sync sensor for the MiniMed 780G system
Drug Approval | April 21, 2025

FDA approves Medtronic’s new Simplera Sync sensor for the MiniMed 780G system

The Simplera Sync is a disposable, all-in-one sensor that requires no fingersticks with SmartGuard


Rockwell Automation empowers NKP Pharma achieve regulatory compliance
Digitisation | April 17, 2025

Rockwell Automation empowers NKP Pharma achieve regulatory compliance

By integrating Rockwell Automation’s FactoryTalk Optix, NKP Pharma has achieved compliance with USFDA 21 CFR Part 11


Biocon Biologics secures market entry date for Yesafili in US
News | April 15, 2025

Biocon Biologics secures market entry date for Yesafili in US

YESAFILI, a vascular endothelial growth factor (VEGF) inhibitor, is used to treat several different types of ophthalmology conditions


Aurobindo receives final ANDA approval for Rivaroxaban Tablets USP, 2.5mg
Drug Approval | April 14, 2025

Aurobindo receives final ANDA approval for Rivaroxaban Tablets USP, 2.5mg

The product will be launched in Q1FY26


FDA approves Opdivo plus Yervoy as treatment metastatic colorectal cancer
Drug Approval | April 12, 2025

FDA approves Opdivo plus Yervoy as treatment metastatic colorectal cancer

The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date


Shilpa Medicare receives US approval for Varenicline Tablets, 0.5 mg and 1 mg
News | April 10, 2025

Shilpa Medicare receives US approval for Varenicline Tablets, 0.5 mg and 1 mg

Shilpa’s product has been approved as a generic version to the innovator - Chantix Tablets, 0.5 mg and 1 mg, of PF Prism C.V. (PF Prism)


Gland Pharma receives approval for Acetaminophen Injection
Drug Approval | April 04, 2025

Gland Pharma receives approval for Acetaminophen Injection

The company expects to launch this product through its marketing partner in the near future


HRV Global Life Sciences delivers Indian anti-diabetic drugs to Argentina
News | April 01, 2025

HRV Global Life Sciences delivers Indian anti-diabetic drugs to Argentina

The consignment of USFDA qualified Metformin (1000mg) was received by the province of Mendoza for distribution in the public health system


Merck seeks FDA approval for subcutaneous pembrolizumab
Drug Approval | March 29, 2025

Merck seeks FDA approval for subcutaneous pembrolizumab

Subcutaneous pembrolizumab administered every six weeks with a median injection time of two minutes, in combination with chemotherapy, shows consistent results across reported efficacy and safety endpoints compared to IV KEYTRUDA in combination with chemotherapy


Briefs: Alembic Pharmaceuticals and Shelter Pharma
News | March 24, 2025

Briefs: Alembic Pharmaceuticals and Shelter Pharma

Alembic Pharmaceuticals successfully completes USFDA inspection for API-III facility