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Results For "approval"

2477 News Found

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


NATCO Pharma receives USFDA approval for Lenalidomide capsules
Policy | May 24, 2021

NATCO Pharma receives USFDA approval for Lenalidomide capsules

NATCO and Arrow shall launch the product on agreed-upon launch dates in the future.


Alembic gets USFDA approval for Lurasidone Hydrochloride tablets
News | May 15, 2021

Alembic gets USFDA approval for Lurasidone Hydrochloride tablets

Lurasidone Hydrochloride tablets are also indicated for adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder


Alembic announces USFDA approval for two drugs
News | May 06, 2021

Alembic announces USFDA approval for two drugs

Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution USP, 2% and 0.5% has an estimated market size of US $80 million for twelve months ending December 2020 according to IQVIA


Natco receives emergency use approval for Baricitinib tablets
News | May 05, 2021

Natco receives emergency use approval for Baricitinib tablets

The company will be requesting a Compulsory License based on emergency use and in light of the grave and serious public health emergency across India due to the Pandemic


Biocon and Viatris receive EC approval for Biosimilar Bevacizumab
Biotech | April 28, 2021

Biocon and Viatris receive EC approval for Biosimilar Bevacizumab

The drug is approved for the treatment in metastatic colorectal carcinoma, metastatic breast cancer and ovarian, cervical and renal cancer


Caplin Steriles gets USFDA approval
News | April 23, 2021

Caplin Steriles gets USFDA approval

The injection comes in multiple formats