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Results For "United-States"

1001 News Found

Eugia Steriles gets 3 observations from USFDA for injectable facility
Drug Approval | April 07, 2024

Eugia Steriles gets 3 observations from USFDA for injectable facility

The observations are procedural in nature and will be responded to within the stipulated time


Gland Pharma receives USFDA approval for Eribulin Mesylate Injection
Drug Approval | April 07, 2024

Gland Pharma receives USFDA approval for Eribulin Mesylate Injection

The Product is expected to be the first generic approval on the market


Merck initiates Phase 3 clinical trial of investigational oral KRAS G12C inhibitor MK-1084
Clinical Trials | April 05, 2024

Merck initiates Phase 3 clinical trial of investigational oral KRAS G12C inhibitor MK-1084

For the first-line treatment of certain patients with metastatic non-small cell lung cancer


EC expands Reblozyl’s approval for treatment of myelodysplastic syndromes
Drug Approval | April 03, 2024

EC expands Reblozyl’s approval for treatment of myelodysplastic syndromes

This is the fourth authorized indication in Europe for Reblozyl, a first-in-class treatment for patients with disease-related anemia


Viatris launches RYZUMVl 0.75% in US
News | April 02, 2024

Viatris launches RYZUMVl 0.75% in US

The average time of dilation lasts three to eight hours


Ultomiris approved in the US for the treatment of adults with neuromyelitis optica spectrum disorder
Drug Approval | March 27, 2024

Ultomiris approved in the US for the treatment of adults with neuromyelitis optica spectrum disorder

First and only long-acting C5 complement inhibitor offers patients with AQP4 Ab+


Zydus receives tentative approval from USFDA for Letermovir Tablets
Drug Approval | March 23, 2024

Zydus receives tentative approval from USFDA for Letermovir Tablets

Letermovir tablets, 240 mg and 480 mg had annual sales of USD 289.5 mn in the United States (IQVIA MAT Jan-24)


Briefs: Concord Biotech and Neuland Laboratories
Drug Approval | March 23, 2024

Briefs: Concord Biotech and Neuland Laboratories

The inspection at Unit 1 by the USFDA has been successfully completed, with no observations under Form 483