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December 15, 2020

FDA Clears First OTC Rapid At-Home COVID Diagnostic Test FDA Clears First OTC Rapid At-Home COVID Diagnostic Test

The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test that can be completed at home […]
December 15, 2020

FDA Approves Shorter Infusion Time for MS Drug Ocrelizumab FDA Approves Shorter Infusion Time for MS Drug Ocrelizumab

The US Food and Drug Administration (FDA) has approved a shorter infusion time for ocrelizumab (Ocrevus) for patients with relapsing or primary progressive multiple sclerosis (MS), […]
December 12, 2020

FDA OKs Emergency Use of Pfizer COVID-19 Vaccine FDA OKs Emergency Use of Pfizer COVID-19 Vaccine

Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. The US Food and Drug Administration (FDA) has authorized Pfizer/BioNTech’s COVID-19 vaccine for emergency use […]
December 11, 2020

FDA Approves Liraglutide for Adolescents With Obesity FDA Approves Liraglutide for Adolescents With Obesity

The Food and Drug Administration’s new indication for liraglutide (Saxenda) for weight loss in adolescents with obesity, announced on Dec. 4, received welcome as a milestone […]
December 4, 2020

FDA Issues Updated Safety Alert for Endologix AAA Repair Grafts FDA Issues Updated Safety Alert for Endologix AAA Repair Grafts

The US Food and Drug Administration (FDA) is reminding clinicians about the need for “at least yearly, lifelong follow-up” to monitor for type III endoleaks in […]
November 26, 2020

New Drug Approved for Neuroblastoma Based on MSKCC Research New Drug Approved for Neuroblastoma Based on MSKCC Research

The US Food and Drug Administration (FDA) has granted accelerated approval for a new drug for certain patients with neuroblastoma based on response rate results in small open-label […]
November 25, 2020

Xofluza Can Now Be Used for Postexposure Flu Prophylaxis Xofluza Can Now Be Used for Postexposure Flu Prophylaxis

The US Food and Drug Administration (FDA) has expanded the indication for the antiviral baloxavir marboxil (Xofluza) to include postexposure prophylaxis of uncomplicated influenza in people […]
November 24, 2020

FDA Clears First Drug to Treat Ultra-Rare Metabolic Disorder FDA Clears First Drug to Treat Ultra-Rare Metabolic Disorder

The US Food and Drug Administration (FDA) has approved lumasiran (Oxlumo, Alnylam Pharmaceuticals) subcutaneous injection to treat children and adults with primary hyperoxaluria type 1 (PH1), […]
November 23, 2020

FDA Authorizes Regeneron’s COVID-19 Monoconal Antibody Treatment FDA Authorizes Regeneron’s COVID-19 Monoconal Antibody Treatment

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. The FDA issued an emergency use authorization to Regeneron Pharmaceuticals for its […]
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