US FDA approval

US FDA grants final approval to Zydus’s Micafungin for injection

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US FDA authorises Novavax’s COVID vaccine as booster for adults

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US FDA grants tentative approval to Zydus’s Amantadine extended-release capsules

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Zydus receives final approval from the US FDA for Sildenafil for oral suspension

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Zydus receives final US FDA approval for Brivaracetam tablets

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US FDA approves Mirabegron extended-release tablets by Zydus

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US FDA grants EIR to Lupin’s Ankleshwar manufacturing facility

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US FDA approves Amylyx’s ALS drug

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US FDA approves Bluebird Bio’s gene therapy for rare neurological disorder

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US FDA approves Mallinckrodt’s Terlivaz for injection to treat Hepatorenal Syndrome 

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