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Results For "USFDA"

1162 News Found

Launches and margin sustainability hold key for Glenmark: ICICI Direct
News | February 15, 2022

Launches and margin sustainability hold key for Glenmark: ICICI Direct

Key takeaways of Q3FY22 quarter & conference call highlights


Lilly's bebtelovimab receives EUA to treat mild-to-moderate Covid-19
Drug Approval | February 14, 2022

Lilly's bebtelovimab receives EUA to treat mild-to-moderate Covid-19

Bebtelovimab neutralizes Omicron as demonstrated by pseudo virus and authentic virus data


Zydus gets 180 days of shared exclusivity for Roflumilast tablets
Drug Approval | February 14, 2022

Zydus gets 180 days of shared exclusivity for Roflumilast tablets

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


Dr Reddy’s launch generic version of Vasostrict in the US
Drug Approval | February 09, 2022

Dr Reddy’s launch generic version of Vasostrict in the US

The Vasostrict brand market had U.S. sales of approximately US $ 878.5 million MAT for the most recent twelve months ending in December 2021 according to IQVIA Health


Sun Pharma demonstrates strong performance on all fronts: ICICI Direct
News | February 04, 2022

Sun Pharma demonstrates strong performance on all fronts: ICICI Direct

Sun Pharma’s Q3FY22 operational performance was in line with I-direct estimates with sustained momentum and good growth across businesses


Granules receives ANDA approval for anti-depressant medication
Drug Approval | February 03, 2022

Granules receives ANDA approval for anti-depressant medication

It has a total of 50 ANDA approvals from USFDA


Lupin signs deal with Axantia to market pegfilgrastim in Middle East and Africa
News | February 01, 2022

Lupin signs deal with Axantia to market pegfilgrastim in Middle East and Africa

Pegfilgrastim is indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients receiving chemotherapy


Israel signs deal to purchase Novavax’ Covid-19 vaccine
Biotech | January 29, 2022

Israel signs deal to purchase Novavax’ Covid-19 vaccine

It would be the first protein-based alternative available in Israel


Granules receives ANDA approval for potassium chloride for oral solution USP, 20 mEq
Drug Approval | January 28, 2022

Granules receives ANDA approval for potassium chloride for oral solution USP, 20 mEq

Potassium chloride is used to prevent or to treat low blood levels of potassium


Glenmark Pharmaceuticals receives ANDA approval for metronidazole vaginal gel, 0.75%
Drug Approval | January 28, 2022

Glenmark Pharmaceuticals receives ANDA approval for metronidazole vaginal gel, 0.75%

Glenmark’s current portfolio consists of 173 products authorized for distribution in the U.S. marketplace and 46 ANDA’s pending approval with the U.S. FDA