Recommendations for Use of Bamlanivimab Plus Etesevimab for Treatment of COVID-19
An FDA panel issued recommendations for use of bamlanivimab plus etesevimab for the treatment of outpatients with mild to moderate COVID-19.
Category: FDA Approvals
FDA Approvals
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FDA Approvals
Latest
FDA Approves Tagrisso for NSC Lung Cancer
The US FDA just approved AstraZeneca's Tagrisso (osimertinib) as the first adjuvant treatment for patients with non-small cell lung cancer whose tumors have a specific type of genetic mutation.
FDA Approvals
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Hollister Introduces AnchorFast Guard Oral Endotracheal Tube Fastener
The AnchorFast endotracheal tube fastener features integrated tube protection for critical care teams that want an extra measure of patient protection.
Trump to FDA Chief: Authorize Pfizer’s Vaccine or Resign
President Trump reportedly ordered FDA chief Stephen Hahn to authorize Pfizer’s COVID-19 vaccine candidate Friday or resign.
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FDA Okays First Combo FLU + COVID-19 Diagnostic for Home Testing
The FDA authorized Quest Diagnostics RC COVID-19 +Flu RT-PCR Test for home collection of patient samples to detect both COVID-19 and influenza A and B (flu).
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FDA Authorizes 3B’s Lumin to Decontaminate N95 Masks
The US FDA has issued an emergency use authorization to 3B Medical’s Lumin UVC System for the decontamination of N95 masks in certain healthcare settings.
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FDA Expands Xofluza Approval Approval for Post-exposure Prevention
The FDA expanded the approved indication for Genetech’s Xofluza (baloxavir marboxil) to include post-exposure prevention of influenza for patients 12 years of age and older after contact with an individual who has the flu.
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FDA Approves ANDA for Intubation Anesthetic
The US FDA approved an abbreviated new drug application for succinylcholine chloride injection USP 200 mg/10 mL, used to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
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FDA Authorizes Regeneron’s Monoclonal Antibody Treatment for COVID-19
The FDA issued an emergency use authorization for Regeneron’s casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in patients 12 and older.
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Baricitinib-Remdesivir Combo Authorized to Treat COVID-19
The FDA issued an EUA for the drug baricitinib in combination with remdesivir to treat patients age two and older who are hospitalized COVID-19.
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FDA Approves Lucira COVID-19 Self-Test with Rapid Results
The FDA has authorized the Lucira COVID-19 All-In-One Test Kit — the first coronavirus diagnostic for self-testing at home and that provides rapid results.
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FDA Authorizes Bamlanivimab for Treatment of COVID-19
The monoclonal antibody bamlanivimab reduced COVID-19-related hospitalization or ER visits in patients at high risk for disease progression within 28 days after treatment.
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Remdesivir First Therapeutic Approved by FDA for COVID-19
The US FDA approved the COVID-19 antiviral drug remdesivir (Veklury, Gilead Sciences) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kg.
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First Mesothelioma Therapeutic Approved in 16 Years
The FDA approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of adults with malignant pleural mesothelioma that cannot be removed by surgery.
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FDA Clears Vida Diagnostics Additions to Lung Imaging Solution
Vida Diagnostics Inc has received 510(k) clearance from the FDA for enhancements to its LungPrint solution.
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