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Results For "U.S.-FDA"

291 News Found

Technology to distinguish between bacterial and viral infections cleared
Medical Device | September 21, 2021

Technology to distinguish between bacterial and viral infections cleared

MeMed BV is a first-of-its-kind test that decodes the immune response to accurately distinguish between bacterial or viral infections within minutes


Glenmark receives ANDA approval for treatment of acne
Drug Approval | September 21, 2021

Glenmark receives ANDA approval for treatment of acne

Clindamycin Phosphate Foam, 1% is the generic version of Evoclin Foam, 1%


Promising prospects for Indian pharma: CLSA
News | September 17, 2021

Promising prospects for Indian pharma: CLSA

CLSA, a capital market and investment group organised an Investors’ Forum where five Indian pharma companies participated. Excerpts from the report


RedHill Biopharma's Opaganib demonstrates strong inhibition of COVID-19 Delta variant
Drug Approval | August 26, 2021

RedHill Biopharma's Opaganib demonstrates strong inhibition of COVID-19 Delta variant

Opaganib, a leading novel small molecule investigational oral pill in development for Covid-19, is a unique host targeted, dual antiviral and anti-inflammatory drug that acts on the cause and effect of the disease


Biocon Q1FY22 revenue up 6% at Rs 1,808 Cr
News | July 23, 2021

Biocon Q1FY22 revenue up 6% at Rs 1,808 Cr

Q1 FY22 consolidated revenue grew 6% to Rs. 1,808 crore from Rs. 1,712 crore in Q1 FY21. Q1 FY22 Net Profit was Rs. 84 crore (vs. Rs. 149 crore in Q1 FY21).


Glenmark receives ANDA tentative approval for Nintedanib Capsules
News | June 26, 2021

Glenmark receives ANDA tentative approval for Nintedanib Capsules

According to IQVIA sales data for the 12 month period ending April 2021, the Ofev Capsules, 100 mg and 150 mg market achieved annual sales of approximately US $1.6 billion


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


Glenmark Pharmaceuticals launches Rufinamide Tablets USP, 200 mg and 400 mg
News | June 02, 2021

Glenmark Pharmaceuticals launches Rufinamide Tablets USP, 200 mg and 400 mg

The Banzel Tablets, 200 mg and 400 mg market2 achieved annual sales of approximately $285.3 million.


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


Lupin launches penicillamine tablets USP
News | March 04, 2021

Lupin launches penicillamine tablets USP

Penicillamine Tablets USP, 250 mg (RLD: Depen) had estimated annual sales of USD 5 million in the U.S. (IQVIA MAT December 2020).