US FDA

US FDA approves Nexviazyme for late-onset Pompe disease

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Alkem Laboratories launches Ibuprofen, Famotidine tablets in US

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Alkem Laboratories says US FDA inspection at Taloja facility ends with ‘zero’ observations

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Granules Pharmaceuticals clears US FDA audit

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US FDA to review full approval of Pfizer/BioNTech’s COVID-19 vaccine by January

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Lupin launches Tavaborole Topical Solution in US

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US FDA adds new warning on J&J COVID-19 vaccine for Guillain-Barre´ syndrome

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Unichem Labs gets tentative US FDA approval for Sitagliptin Tablets USP

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Lupin gets USFDA approval of sNDA for SOLOSEC (secnidazole) to treat trichomoniasis

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US FDA accepts Amneal’s Biologics License Application for Bevacizumab

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