Tara Thigpen

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Latest Posts › Food and Drug Administration (FDA)

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FDA Approves BLA for Novavax’s COVID-19 Vaccine

On May 19, Novavax, Inc. (“Novavax”) announced that FDA approved its Biologics License Application (“BLA”) for Nuvaxovid™ for active immunization against COVID-19 in adults 65 years and older and individuals 12 through 64...more

5/27/2025 / Contract Terms , Coronavirus/COVID-19 , FDA Approval , Food and Drug Administration (FDA) , IP License , Pharmaceutical Industry , Prescription Drugs , Sanofi

FDA Approves Celltrion’s OMLYCLO® (omalizumab-igec)

On March 9, 2025, Celltrion announced that the FDA has approved OMLYCLO® (omalizumab-igec), the first and only biosimilar of XOLAIR® (omalizumab)....more

3/19/2025 / Biosimilars , Celltrion , FDA Approval , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs

Fresenius and Formycon Receive EC and FDA Approval of Ustekinumab Biosimilar

On September 27, 2024, Formycon AG (“Formycon”) and its commercialization partner Fresenius Kabi (“Fresenius”) jointly announced that the European Commission (EC) has issued a marketing authorization for FYB202/OTULFI™...more

10/7/2024 / Biosimilars , EU , European Medicines Agency (EMA) , Food and Drug Administration (FDA) , Marketing Authorization Application , Pharmaceutical Industry , Prescription Drugs

STADA and Alvotech Announce Launch of UZPROVO® in Europe

On July 22, 2024, STADA Arzeimittel AG (“STADA”) and Alvotech announced the launch of ustekinumab biosimilar AVT04 under the name UZPROVO® across a majority of European countries. UZPROVO®, the first approved...more

7/29/2024 / Biosimilars , EU , European Medicines Agency (EMA) , FDA Approval , Food and Drug Administration (FDA) , Pharmaceutical Industry , Pharmaceutical Patents

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