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Results For "approval"

2612 News Found

Poxel and Sumitomo Dainippon gets TWYMEEG approval
News | June 25, 2021

Poxel and Sumitomo Dainippon gets TWYMEEG approval

The TWYMEEG approval is supported by numerous preclinical and clinical studies, including the Phase 3 TIMES (Trials of IMeglimin for Efficacy and Safety) program managed jointly by both the companies


Zydus Cadila receives USFDA approval for Fingolimod capsules
News | June 25, 2021

Zydus Cadila receives USFDA approval for Fingolimod capsules

Fingolimod is an immunomodulating drug. It is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis


Glenmark receives ANDA approval for inhalation solution
News | June 24, 2021

Glenmark receives ANDA approval for inhalation solution

Arformoterol Tartrate Inhalation Solution, 15 mcg/2 mL, Unit-Dose Vials will be manufactured in the company’s North American manufacturing facility based in Monroe, North Carolina


Cipla receives final approval for generic version of Brovana
News | June 24, 2021

Cipla receives final approval for generic version of Brovana

Arformoterol Tartrate Inhalation Solution 15 mcg/2 mL is AN-rated generic therapeutic equivalent version of Sunovion Pharmaceuticals Inc.’s Brovana


Zydus Cadila receives tentative USFDA approval for Brivaracetam
News | June 15, 2021

Zydus Cadila receives tentative USFDA approval for Brivaracetam

The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad


Lupin receives U.S. FDA approval for HIV-1 drug
Pharma | June 08, 2021

Lupin receives U.S. FDA approval for HIV-1 drug

Emtricitabine and Tenofovir Disoproxil Fumarate tablets had estimated annual sales of US $2.1 billion in the U.S. according to IQVIA MAT March 2021


Glenmark receives ANDA approval for theophylline extended-release tablets
News | June 07, 2021

Glenmark receives ANDA approval for theophylline extended-release tablets

Glenmark has been granted a competitive generic therapy (CGT) designation for theophylline extended-release tablets


Zydus Cadila receives tentative approval from USFDA for lung cancer drugs
Policy | June 03, 2021

Zydus Cadila receives tentative approval from USFDA for lung cancer drugs

Osimertinib works by slowing or stopping the growth of cancer cells and binds to a certain protein (epidermal growth factor receptor-EGFR) in some tumors


Zydus seeks DCGI approval for monoclonal antibodies cocktail
Policy | May 27, 2021

Zydus seeks DCGI approval for monoclonal antibodies cocktail

Cocktails of 2 mAbs based products are better equipped to deal with variants than single mAb based products which have a tendency of losing their efficacy with rapidly generating variants


Glenmark receives ANDA approval for Icatibant Injection
News | May 25, 2021

Glenmark receives ANDA approval for Icatibant Injection

This marks Glenmark's first synthetic decapeptide injectable approval