Daniel Wittenberg

Snell & Wilmer

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Latest Posts › FDA Approval

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Regulatory Matters – FDA Updates Emergency Use Authorization for Paxlovid

A little over two years ago, the FDA authorized Paxlovid for emergency use for the treatment of adults and pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe...more

1/31/2024 / Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , FDA Approval , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs

FDA Approves Second Booster

Yesterday, the FDA authorized a second COVID-19 booster dose for Americans ages 50 and older, along with some immunocompromised individuals, at least four months after their initial booster....more

3/31/2022 / Centers for Disease Control and Prevention (CDC) , Coronavirus/COVID-19 , FDA Approval , Food and Drug Administration (FDA) , Infectious Diseases , Vaccinations

FDA Approves Second Biosimilar – Inflectra™ – The First Monoclonal Antibody Biosimilar

The U.S. Food and Drug Administration announced on April 5 its second ever approval of a biosimilar – Inflectra (infliximab-dyyb) – for multiple indications. Inflectra was developed by Celltrion Inc. and licensed to Pfizer...more

4/8/2016 / Affordable Care Act , Biosimilars , BPCIA , FDA Approval , Food and Drug Administration (FDA) , Patent Infringement , Pfizer , Pharmaceutical Patents

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